Shiley, Inc.
Medical device manufacturer in Irvine, CA.
174510(k) clearances
0PMA approvals
0recalls
Device types
- DWF Catheter, Cannula And Tubing, Vascular… 21
- DTN Reservoir, Blood, Cardiopulmonary Bypass 14
- BTO Tube, Tracheostomy (W/Wo Connector) 13
- DTR Heat-Exchanger, Cardiopulmonary Bypass 11
- CAC Apparatus, Autotransfusion 11
- DTZ Oxygenator, Cardiopulmonary Bypass 10
- LFJ Catheter, Subclavian 7
- DXE Catheter, Embolectomy 5
- BTR Tube, Tracheal (W/Wo Connector) 5
- DSY Prosthesis, Vascular Graft, Of 6mm And… 5
- KRI Accessory Equipment, Cardiopulmonary Bypass 4
- DTP Defoamer, Cardiopulmonary Bypass 4
- DTM Filter, Blood, Cardiopulmonary Bypass… 3
- JOH Tube Tracheostomy And Tube Cuff 3
- DQO Catheter, Intravascular, Diagnostic 3
- FLL Continuous Measurement Thermometer 3
- DQR Cannula, Catheter 3
- DTQ Console, Heart-Lung Machine… 3
- DWB Pump, Blood, Cardiopulmonary Bypass, Roller… 3
- DTL Adaptor, Stopcock, Manifold, Fitting… 2
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K920594 | Shiley Perfusion Tubing SetsDTM · Traditional | 03/18/1993SE |
| K910991 | Shiley Therapeutic Autotransfusion SystemCAC · Traditional | 11/27/1991SE |
| K911876 | Shiley Plexus(R) Venous Reservoir, PVR1200DTN · Traditional | 08/09/1991SE |
| K910923 | BCD AdvancedDTR · Traditional | 04/09/1991SE |
| K901548 | Biomedical Sensors-Shiley BGM 4000 Intra Blood GasCCC · Traditional | 01/14/1991SE |
| K903435 | Shiley Specialized Tracheostomy TubeJOH · Traditional | 10/02/1990SE |
| K901624 | Shiley Plexus Integral Reservoir Hollow Fiber Oxy.DTZ · Traditional | 07/03/1990SE |
| K901250 | Plexus 2(TM) Infant Hollow Fiber OxygenatorDTZ · Traditional | 06/11/1990SE |
| K901249 | Plexus 3.5(TM) Pediatric Hollow Fiber OxygenatorDTZ · Traditional | 06/11/1990SE |
| K900797 | Stockert Shiley Dual Pressure Control Module XRDXS · Traditional | 05/10/1990SE |
| K900548 | Shiley Phonation ValveBTO · Traditional | 04/23/1990SE |
| K900753 | Shiley Vein Irrigation Cannula (Beveled & Blunt)DWF · Traditional | 04/10/1990SE |
| K900186 | Bonchek-Shiley Cardiac Jacket W/Recirculation SetDWJ · Traditional | 04/10/1990SE |
| K900339 | Hand-Held Intracardiac Suckers W/Ergonomic HandlesDTS · Traditional | 03/28/1990SE |
| K894784 | Modified Shiley Femoral Venous CannulaDQR · Traditional | 03/28/1990SE |
| K893711 | Dideco-Shiley Autotransfusion Cardiotomy ReservoirDTN · Traditional | 02/28/1990SE |
| K895150 | Continucath 1000 Intravascular Oxygen MonitoringCCE · Traditional | 11/28/1989SE |
| K895149 | Neocath 1000 Umbilical Artery Oxygen Monitoring SyCCE · Traditional | 11/28/1989SE |
| K895388 | Shiley Elbow 15MM Swivel ConnectorBZA · Traditional | 10/27/1989SE |
| K894668 | Modified Shiley Therapeutic Autotransfusion SystemCAC · Traditional | 10/20/1989SE |
| K894630 | Shiley Plexus(Tm) Adult Hollow Fiber OxygenatorDTZ · Traditional | 10/20/1989SE |
| K894681 | Revised Labeling for Arterial Embolectomy CatheterDXE · Traditional | 10/12/1989SE |
| K894294 | Dideco-Shiley Universal YCAC · Traditional | 08/15/1989SE |
| K890194 | Shiley Specialized Tracheostomy TubeJOH · Traditional | 07/20/1989SE |
| K892446 | Shiley Equipment Support Carts ESC-002 & ESCB-02KRD · Traditional | 07/14/1989SE |
| K884564 | Shiley Therapeutic Autotransfusion System-ProgrammCAC · Traditional | 05/05/1989SE |
| K890980 | Modified Stockert-Shiley Venous CatheterDWF · Traditional | 05/01/1989SE |
| K890904 | Modified Stockert-Shiley Caps Multi. Roller PumpDWB · Traditional | 04/12/1989SE |
| K884872 | Dideco-Shiley Autotransfusion Cardiotomy ReservoirDTN · Traditional | 01/30/1989SE |
| K884730 | Shiley Perc Tracheostomy SystemBTO · Traditional | 01/17/1989SE |
| K884393 | Modified Shiley Femoral Arterial CannulaDWF · Traditional | 12/27/1988SE |
| K883332 | Mast for Basic Heater-Cooler Unit 16-09-00DTR · Traditional | 09/26/1988SE |
| K883331 | Basic Heater-Cooler Unit W/Mast, 115/110V 16-21-10DTR · Traditional | 09/26/1988SE |
| K883330 | Basic Heater-Cooler Unit, 115/100V 16-02-20DTR · Traditional | 09/26/1988SE |
| K881692 | Dideco-Shiley Fluid Collection BagCAC · Traditional | 07/08/1988SE |
| K881733 | Shiley Femoral Coronary Perfusion CatheterDWF · Traditional | 07/06/1988SE |
| K881734 | Shiley Femoral Left Ventricular Vent CatheterDWF · Traditional | 07/05/1988SE |
| K881691 | Preassembled Surgical Wash Set 122,175,225,375AADWF · Traditional | 07/05/1988SE |
| K881683 | Dideco-Shiley Autotrans BT 795/AACAC · Traditional | 06/27/1988SE |
| K881073 | Shiley Femoral Cannulae Introducer KitDRE · Traditional | 06/09/1988SE |
| K881074 | Shiley Femoral Venous CannulaDWF · Traditional | 05/31/1988SE |
| K881072 | Shiley Femoral Arterial CannulaDWF · Traditional | 05/31/1988SE |
| K881006 | Stockert-Shiley Bubble Monitor 23-23-01DRY · Traditional | 05/24/1988SE |
| K880663 | Shiley BCD Plus Heat ExchangerDTR · Traditional | 05/11/1988SE |
| K881421 | Dideco-Shiley Feed Tube Support Arms and HookCAC · Traditional | 05/04/1988SE |
| K881290 | Modified Shiley Dual Lumen Subclavian CannulaLFJ · Traditional | 04/27/1988SE |
| K880614 | Shiley Disp. Cannula Cuffless Traceostomy TubeBTO · Traditional | 03/09/1988SE |
| K880247 | Modified Shiley Low Pressure Cuffed Tracheo. TubesBTO · Traditional | 02/12/1988SE |
| K872719 | Expanded Use of Hardshell Venous Reserv. W/FilterDTN · Traditional | 09/30/1987SE |
| K872722 | Expanded Use for Shiley 3L Cardf PlusDTN · Traditional | 09/23/1987SE |
| K872721 | Expanded Use for Shiley 3L Cardiotomy ReservoirDTN · Traditional | 09/23/1987SE |
| K872720 | Shiley PTS Chest Drainage Autotransfusion SetDTN · Traditional | 09/23/1987SE |
| K872161 | Dideco-Shiley Preassembled Surgical Wash SetDTL · Traditional | 08/12/1987SE |
| K872159 | Dideco-Shiley Autotransfusion AccessoriesDWF · Traditional | 08/12/1987SE |
| K872814 | Shiley Therapeutic Autotransfusion System (Remote)CAC · Traditional | 08/05/1987SE |
| K872160 | Dideco-Shiley Blood Separation Wash BowlCAC · Traditional | 07/24/1987SE |
| K872162 | Dideco-Shiley Blood Reinfusion BagCAC · Traditional | 07/21/1987SE |
| K872158 | Dideco-Shiley Waste Collection BagCAC · Traditional | 07/21/1987SE |
| K871596 | Ionescu-Shiley Pericardial Xenograft (Isu)DTJ · Traditional | 06/15/1987SE |
| K870826 | Additional Letter Designation for Aortic Arch Can.DQR · Traditional | 03/23/1987SE |
| K870825 | New Model Styles for Aortic Arch CannulaDQR · Traditional | 03/23/1987SE |
| K864890 | Stockert-Shiley Caps Venous Occlusion ClampKRI · Traditional | 02/19/1987SE |
| K864787 | Schneider-Shiley Guide WireDQX · Traditional | 02/19/1987SE |
| K864619 | Caps Low Level Detector & Detector/Bubble MonitorKRL · Traditional | 02/03/1987SE |
| K865061 | Shiley Dispos Cannula Fenes LP Cuffed Trache TubeBTO · Traditional | 01/15/1987SE |
| K863960 | Stockert-Shiley Caps Battery ModuleDTQ · Traditional | 12/11/1986SE |
| K863541 | Stockert-Shiley Caps HLM InterfaceDTQ · Traditional | 11/18/1986SE |
| K863697 | Modified Silicone Dual Lumen Subclavian CannulaLFJ · Traditional | 10/02/1986SE |
| K862973 | Stockert-Shiley Caps Timer ModuleDTQ · Traditional | 10/01/1986SE |
| K862836 | Stockert-Shiley Caps and Caps Dual Pressure ModuleDXS · Traditional | 09/12/1986SE |
| K862466 | Schneider-Shiley Flushing CatheterDQO · Traditional | 08/29/1986SE |
| K862464 | Schneider-Shiley Y-Connector with RotatorDQO · Traditional | 08/28/1986SE |
| K862467 | Schneider-Shiley Seldinger Initial Puncture InstrLIT · Traditional | 08/11/1986SE |
| K862465 | Schneider-Shiley Occluder/Flushing Cath. StopcockDQO · Traditional | 08/11/1986SE |
| K862510 | Stockert-Shiley Caps 4 Channel Temp. Monitor 1KRI · Traditional | 07/17/1986SE |
| K862116 | Stockert-Shiley Double Head Pump ModuleDWB · Traditional | 07/16/1986SE |
| K861714 | Stockert-Shiley Multiflow Roller Pump ModuleDWB · Traditional | 07/16/1986SE |
| K861607 | Schneider-Shiley Inflation SyringesMAV · Traditional | 06/09/1986SE |
| K861606 | Schneider-Shiley Wire TorquerDQX · Traditional | 06/09/1986SE |
| K861310 | Stockert-Shiley Aortic Root CannulaeDWF · Traditional | 05/30/1986SE |
| K861605 | Schneider-Shiley Pressure ManometerKRK · Traditional | 05/28/1986SE |
| K861496 | Stockert-Shiley Venous Cath & Aortic Arch CannulaDWF · Traditional | 05/27/1986SE |
| K860920 | Stockert-Shiley Heater/Cooler Temperature ControlDTR · Traditional | 05/21/1986SE |
| K861463 | Shiley Sleep Apnea Low Pressure Cuffed Trach TubeBTR · Traditional | 05/06/1986SE |
| K861462 | Shiley Sleep Apnea Cuffless Tracheostomy TubeBTR · Traditional | 05/06/1986SE |
| K861461 | Shiley Sleep Apnea Cuffless Fenestrated Trach TubeBTR · Traditional | 05/06/1986SE |
| K861174 | Shiley Silicone Dual Lumen Subclavian CannulaLFJ · Traditional | 04/23/1986SE |
| K854319 | Schneider-Shiley Peripheral Dilatation CatheterLIT · Traditional | 03/31/1986SE |
| K854841 | Shiley Venous ReservoirDTN · Traditional | 02/10/1986SE |
| K854640 | Modified Coronary Cardioplegia AdaptorDWF · Traditional | 02/10/1986SE |
| K853503 | Shiley 3L Cardiotomy ReservoirDTP · Traditional | 11/14/1985SE |
| K852984 | Shiley CSD Extension Line with FilterDWF · Traditional | 10/11/1985SE |
| K852780 | BCD Plus Blood Cardioplegia Sys(Hereaf Refer Dev)DTR · Traditional | 09/30/1985SE |
| K852070 | Shiley Silicone Sual Lumen Subclavian CannualLFJ · Traditional | 06/13/1985SE |
| K843232 | Shiley Hardshell Venous Reservoir W/IntDTN · Traditional | 01/14/1985SE |
| K844140 | Stockert-Shiley Atrial Left Ventricular Vent CathDWF · Traditional | 12/27/1984SE |
| K844139 | Stockert-Shiley Intracardiac SuckersDWF · Traditional | 12/27/1984SE |
| K844138 | Stockert-Shiley Handheld Remote Control IntracardiDWF · Traditional | 12/27/1984SE |
| K844137 | Stockert-Shiley Venous Catheter & Aortic Arch CannDWF · Traditional | 12/27/1984SE |
| K843802 | Stockert-Shiley Universal Level SensorDTW · Traditional | 12/27/1984SE |
| K843730 | Shiley Dispos. Decannulation Plug W/Sw/BTO · Traditional | 10/19/1984SE |
| K843729 | Shiley Dispos. Cannula Fenestrated LowBTO · Traditional | 10/19/1984SE |
| K843542 | Shiley Coronary Cardioplegia AdaptorDWF · Traditional | 10/18/1984SE |
| K831822 | Tetraflex Integrally Supported PTFEDSY · Traditional | 10/16/1984SE |
| K842337 | Shiley Venous ReservoirDTN · Traditional | 08/17/1984SE |
| K842711 | Shiley Cardiotomy Reservoir W/FilterDTN · Traditional | 08/10/1984SE |
| K841797 | Multipro CatheterDQY · Traditional | 08/10/1984SE |
| K840198 | Arterial Embolectomy CatheterDXE · Traditional | 08/03/1984SE |
| K841789 | Sechrist Air-Oxygen Mixer & AncillaryBZR · Traditional | 07/26/1984SE |
| K840197 | Single Lumen Subclavian CannulaLFJ · Traditional | 04/25/1984SE |
| K840603 | Arterial Filter Purge Line W/Check ValvDTL · Traditional | 04/19/1984SE |
| K840450 | Shiley Prebypass FilterKRJ · Traditional | 04/17/1984SE |
| K833830 | 3-DAY Bioindicator Release Process forDWF · Traditional | 04/12/1984SE |
| K833981 | Shiley Dispos. Temp. ProbesFLL · Traditional | 03/27/1984SE |
| K833831 | 3-DAY Bioindicator Release for SterilBTR · Traditional | 03/21/1984SE |
| K833832 | 3-DAY Bioindicator Release for RespirBTO · Traditional | 03/15/1984SE |
| K840539 | Dispos. Low Press. Cuffed TracheostomyBTO · Traditional | 03/09/1984SE |
| K833555 | Lal Test Release & Bonchek Car/JacketDTR · Traditional | 02/04/1984SE |
| K833848 | Dual Lumen Subclavian CannulaLFJ · Traditional | 12/08/1983SE |
| K833253 | Shiley M2000 Membrane OxygenatorDTZ · Traditional | 12/01/1983SE |
| K832924 | Venous ReservoirDTN · Traditional | 10/31/1983SE |
| K831894 | Blood Oxygenator 5070DTZ · Traditional | 10/20/1983SE |
| K831895 | Blood Oxygenator 50 70/SDTZ · Traditional | 10/19/1983SE |
| K831880 | Ionescu-Shiley Low Porosity Aortic GraftDSY · Traditional | 10/19/1983SE |
| K831865 | Ionescu-Shiley Low Porosity CompositeDSY · Traditional | 10/19/1983SE |
| K832704 | Shiley Gas FilterKRI · Traditional | 09/29/1983SE |
| K832044 | Shiley Multipro CatheterDXE · Traditional | 09/29/1983SE |
| K832811 | Shiley 3L Cardf PlusDTP · Traditional | 09/20/1983SE |
| K823345 | PatchDXZ · Traditional | 03/10/1983SE |
| K823731 | CardfDTP · Traditional | 01/05/1983SE |
| K823533 | Jacket & SetDTR · Traditional | 12/30/1982SE |
| K821993 | Shiley Laryngectomy TubeKAC · Traditional | 08/12/1982SE |
| K822134 | Shiely Duel Lumen Subclavian CannulaLFJ · Traditional | 08/03/1982SE |
| K821261 | Puig Massana-Shiley Annuloplasty RingKRH · Traditional | 06/16/1982SE |
| K821244 | Disposable Temperature ProbeFLL · Traditional | 05/14/1982SE |
| K821027 | Soft Tip Low Pressure Cuffed Oral/NasalBTR · Traditional | 05/03/1982SE |
| K813276 | Ionescu-Shiley Valve Holder & HandleDTJ · Traditional | 12/10/1981SE |
| K812742 | Shiley Arterial Filter W/40 Micron ScreeDTM · Traditional | 11/02/1981SE |
| K812302 | Shiley Fenestrated Low Press. CuffedJOH · Traditional | 09/08/1981SE |
| K811447 | Shiley Disposable Cannula Trach. TubeBTO · Traditional | 06/26/1981SE |
| K811379 | Shiley Arterial FilterDTM · Traditional | 06/09/1981SE |
| K811204 | Bronchek-Shiley Cardiac Jacket & BSC JDTR · Traditional | 05/21/1981SE |
| K811033 | Shiley Low Pressure Thin-Cuffed TrachBTO · Traditional | 05/13/1981SE |
| K810470 | Shiley S-100A (Adult) Blood OxygenatorDTZ · Traditional | 04/17/1981SE |
| K810647 | Shiley Oxygenator Thermistor ProbeDWC · Traditional | 04/03/1981SE |
| K810106 | Shiley Single Cannula Tracheostomy TubeBTO · Traditional | 02/02/1981SE |
| K803000 | Ionescu-Shiley Aortic Graft ValveDSY · Traditional | 02/02/1981SE |
| K802879 | Buckberg-Shiley Blood Cardioplegic Spl.DTR · Traditional | 12/19/1980SE |
| K801879 | Puig Massana-Shiley Annuloplasty RingKRH · Traditional | 12/16/1980SE |
| K802147 | Shiley Temperature MonitorFLL · Traditional | 09/16/1980SE |
| K802119 | Shiley Utility ReservoirDTN · Traditional | 09/16/1980SE |
| K801764 | Ionescu-Shiley Pericardial PatchDXZ · Traditional | 08/13/1980SE |
| K801375 | Shiley Cardiotomy Reservoir W/FilterDTP · Traditional | 07/14/1980SE |
| K792222 | Shiley Low Pressure Thin-Cuffed Trach.EQN · Traditional | 12/18/1979SE |
| K792134 | Bonchek-Shiley Vein Distention SystemDWP · Traditional | 12/04/1979SE |
| K792265 | Shiley Pressure Relief Adapter PraBSK · Traditional | 11/27/1979SE |
| K791947 | Shiley Cardioplegic Solution del SetsDWF · Traditional | 11/13/1979SE |
| K791829 | Shiley Quick Disconnect AssemblyKRI · Traditional | 10/02/1979SE |
| K791828 | Bjork-Shiley Pulmonic Graft ValveDSY · Traditional | 09/27/1979SE |
| K791225 | Bjork-Shiley Aortic Graft Valve ProsthDXY · Traditional | 08/10/1979SE |
| K790938 | Saphenous Vein Irrigation, PressurizatioDWP · Traditional | 06/13/1979SE |
| K790838 | Arterial Embolectomy Catheter (Modified)DXE · Traditional | 06/11/1979SE |
| K790425 | Ionescu-Shiley Composite Conduit-Pulmoni · Traditional | 03/28/1979SE |
| K781990 | Cardiac Insulation PadDWF · Traditional | 12/04/1978SE |
| K781639 | Shiley Cricothyrotomy TubeEQN · Traditional | 10/24/1978SE |
| K780772 | Bjork-Shiley Cardiac Heart Valve · Traditional | 09/01/1978SE |
| K781223 | Oxygenator, Blood, Infant/PediatricDTZ · Traditional | 07/27/1978SE |
| K780788 | Irrigation CatheterGBX · Traditional | 06/22/1978SE |
| K780762 | Embolectomy Catheter, Extend. Shelf LifeDXE · Traditional | 05/26/1978SE |
| K780220 | Hood, Infant OxygenFOG · Traditional | 04/10/1978SE |
| K772237 | Oxygenator, BubbleDTZ · Traditional | 12/13/1977SE |
| K770218 | Shiley Pediatric Murphy Endotrach. TubeBTO · Traditional | 02/09/1977SE |
| K770036 | Cardiotomy ReservoirDTN · Traditional | 01/14/1977SE |
| K760922 | Perfusion Tubing SetKDL · Traditional | 11/19/1976SE |