Scimed Life Systems, Inc.
Medical device manufacturer in Maple Grove, MN.
109510(k) clearances
2PMA approvals
0recalls
Device types
- DQX Wire, Guide, Catheter 30
- DQY Catheter, Percutaneous 17
- DQO Catheter, Intravascular, Diagnostic 16
- LIT Catheter, Angioplasty, Peripheral… 13
- KRA Catheter, Continuous Flush 6
- DTZ Oxygenator, Cardiopulmonary Bypass 6
- DTP Defoamer, Cardiopulmonary Bypass 4
- DTR Heat-Exchanger, Cardiopulmonary Bypass 3
- DTN Reservoir, Blood, Cardiopulmonary Bypass 3
- DTL Adaptor, Stopcock, Manifold, Fitting… 3
- MAV Syringe, Balloon Inflation 2
- LOX Catheters, Transluminal Coronary… 1
- KRI Accessory Equipment, Cardiopulmonary Bypass 1
- DRF Catheter, Electrode Recording, Or Probe… 1
- MFY Endothelial Cell Harvesting Kit 1
- DXZ Patch, Pledget And Intracardiac, Petp… 1
- DXT Injector And Syringe, Angiographic 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K974241 | Scimed Informer Pressure Wire SystemDQX · Traditional | 11/12/1998SE |
| K981788 | Scimed 6 French Wiseguide Guide CatheterDQO · Traditional | 08/18/1998SE |
| K980360 | Scimed Quest Floppy and Moderate Support Guide WiresDQX · Traditional | 04/29/1998SE |
| K974559 | Scimed 6 French Impulse Angiographic CathetersDQO · Traditional | 02/23/1998SE |
| K974684 | Scimed 7 French Wiseguide Guide CatheterDQY · Traditional | 02/19/1998SE |
| K973945 | Luge Guide WireDQX · Traditional | 01/12/1998SE |
| K970823 | Scimed 8 French Wiseguide Guide CatheterDQY · Traditional | 06/03/1997SE |
| K964551 | Choice Super Support Ptca Guide Wire, Choice Plus Super Support Ptca Guide Wire, Choice…DQX · Traditional | 05/21/1997SE |
| K970244 | Scimed Choice Family of Ptca Guide WiresDQX · Traditional | 03/28/1997SE |
| K965023 | Choice PT Plus Ptca Guide Wire and Choice PT Vision Ptca Guide WireDQX · Traditional | 03/04/1997SE |
| K964859 | Scimed 5 French Impulse Angiographic CathetersDQO · Traditional | 02/10/1997SE |
| K962572 | Scimed Choice PT Vision Ptca Guide WireDQX · Traditional | 12/17/1996SE |
| K961294 | Scimed Dispatch Gold Coronary CatheterKRA · Traditional | 07/03/1996SE |
| K961280 | Scimed 6-10 F Triguide Guide Catheters 6F,7F,8F,9F & 10FDQY · Traditional | 05/15/1996SE |
| K961015 | Scimed Choice/Ptca Guide Wire/Plus Ptca Guide Wire/Exchange Ptca Guide WireDQX · Traditional | 05/15/1996SE |
| K960657 | Scimed Choice PT Exchange Extra Support Ptca and Long Taper Ptca Guide WireDQX · Traditional | 04/29/1996SE |
| K960563 | Scimed Sceptor & Sceptor Exchange Ptca Guide WiresDQX · Traditional | 04/29/1996SE |
| K955869 | Scimed Encore 26 Inflation Device/Encore 30 Inflation DeviceMAV · Traditional | 03/22/1996SE |
| K953133 | Scimed Dispatch Coronary Infusion CatheterKRA · Traditional | 02/23/1996SE |
| K953265 | Scimed Angiographic KitsDQY · Traditional | 01/16/1996SE |
| K953515 | Scimed Triguide Guide CathetersDQY · Traditional | 09/19/1995SE |
| K952872 | Sscimed Coronary Guide Wire/Infusion CatheterKRA · Traditional | 07/27/1995SE |
| K951802 | Scimed Encore Advantage Kit and the Essentials KitDXT · Traditional | 07/21/1995SE |
| K951720 | Scimed Expo Angiographic CatheterDQO · Traditional | 06/22/1995SE |
| K950216 | Scimed Choice PT Plus(Rm) Ptca Guide WireDQX · Traditional | 06/22/1995SE |
| K951089 | Scimed Gateway PlusDTL · Traditional | 05/31/1995SE |
| K950835 | Scimed Choice PT Ptca Guide WireDQX · Traditional | 05/25/1995SE |
| K950535 | Scimed Sceptor Exchange Guide WireDQX · Traditional | 04/28/1995SE |
| K950534 | Scimed Sceptor Ptca Guide WireDQX · Traditional | 04/28/1995SE |
| K950266 | Scimed(R) Choice(Tm) PT Exchange Ptca Guide WireDQX · Traditional | 04/14/1995SE |
| K950731 | Scimed 6 French Expo Angiographic CatheterDQO · Traditional | 04/05/1995SE |
| K950141 | Scimed(R) Choice(Tm) Ptca Guide WireDQX · Traditional | 03/31/1995SE |
| K950113 | Scimed(R) Chice(Tm) Exchange Ptca Guide WireDQX · Traditional | 03/31/1995SE |
| K946240 | Scimed(R) Sceptor(Tm) Ptca Guide WireDQX · Traditional | 03/31/1995SE |
| K946180 | Scimed(R) Entre Ptca Guide WireDQX · Traditional | 03/17/1995SE |
| K946204 | Scimed(R) Triduige(R) Guide CathetersDQY · Traditional | 03/13/1995SE |
| K950094 | Scimed 6 French Micro-Max(Tm) Guide CatheterDQY · Traditional | 03/03/1995SE |
| K945129 | Scimed Chioce Plus Ptca Guide WireDQX · Traditional | 03/03/1995SE |
| K945593 | Scimed(R) Coronary Guide Wire Exchange/Infusion CatheterKRA · Traditional | 01/13/1995SE |
| K945159 | Scimed Pursuit Exchange Ptca Guide WireDQX · Traditional | 12/30/1994SE |
| K943192 | Scimed Choice(Tm) Ptca Guide WireDQO · Traditional | 11/22/1994SE |
| K944815 | Scimed Viper Percutaneous Transluminal Angioplasty (Pta) CatheterLIT · Traditional | 11/14/1994SE |
| K944537 | Scimed Triguide Guide CatheterDQY · Traditional | 10/21/1994SE |
| K943783 | 7 French Large Lumen Triguide-PlusDQY · Traditional | 10/13/1994SE |
| K943777 | Scimed 8 French Big-Max Guide CatheterDQY · Traditional | 10/13/1994SE |
| K942333 | Scimed En Tre' III Ptca Guide WireDQX · Traditional | 08/31/1994SE |
| K931335 | Scimed(R) Venture(Tm) Infusion CatheterKRA · Traditional | 07/27/1994SE |
| K941137 | Scimed Triguide Guiding CatheterDQY · Traditional | 06/22/1994SE |
| K941895 | Scimed 0.014 Ptca Guide Wire with Ice Hydrophilic CoatingDQX · Traditional | 05/24/1994SE |
| K934541 | Scimed 6 French Angiographic Catheter ModificationDQO · Traditional | 05/12/1994SE |
| K940545 | Scimed 10 FR Large Lumen Triguide-Flex Guid CathDQY · Traditional | 05/06/1994SE |
| K940603 | Scimed 8 French Triguide Guiding CatheterDQY · Traditional | 04/19/1994SE |
| K934581 | Scimed 5, 7, and 8 French Angiographic CathetersDQO · Traditional | 03/31/1994SE |
| K935905 | Scimed Entre Ptca Guide Wire with J-TipDQX · Traditional | 03/10/1994SE |
| K935654 | Scimed 10 Fr. Lg. Lumen Triguide Plus(Tm) Guid CathDQO · Traditional | 02/22/1994SE |
| K935577 | Scimed Entre II Ptca Guide WireDQX · Traditional | 02/14/1994SE |
| K935022 | Scimed Entre II Ptca Guide Wire ModificationDQX · Traditional | 01/18/1994SE |
| K934378 | Scimed Maverick Percutaneous Transluminal Angioplasty (Pta) CatheterLIT · Traditional | 01/18/1994SE |
| K934988 | 9 French Large Lumen Triguide Plus Guiding CatheterDQY · Traditional | 01/14/1994SE |
| K932616 | Scimed(R) Dispatch(Tm) Coronary Infusion CatheterKRA · Traditional | 12/15/1993SE |
| K932537 | Scimed Maverick Pta CatheterLIT · Traditional | 12/08/1993SE |
| K933183 | Scimed ViperLIT · Traditional | 09/09/1993SE |
| K932420 | Scimed 6 Fr., 7 Fr., and 8 Fr.,Triguide GuidingDQO · Traditional | 08/17/1993SE |
| K932542 | Scimed 6F Angiographic CatheterDQO · Traditional | 08/11/1993SE |
| K931514 | Scimed(R) Entre(Tm) II Ptca Guide Wire & AccessoryDQX · Traditional | 06/25/1993SE |
| K925608 | Scimed Encore(Tm) Advantage Kit/Essentials KitMFY · Traditional | 06/16/1993SESK |
| K925945 | Maverick Percutaneous Transluminal Angioplasty CatLIT · Traditional | 05/20/1993SE |
| K926457 | Scimed(R) 0.038 Controlwire(Tm) Peripher Guide WirDQX · Traditional | 04/08/1993SE |
| K923245 | Triguide-Plus Guiding CatheterDQY · Traditional | 02/12/1993SE |
| K922611 | Scimed 6 Fr. Triguide - Elite Guiding CatheterDQY · Traditional | 01/11/1993SE |
| K923826 | Parametric Process ControlLIT · Traditional | 10/22/1992SE |
| K921577 | Scimed Sidewinder Tuohy-Borst Y-AdapterLIT · Traditional | 10/16/1992SE |
| K923480 | Scimed Entre Ptca Guide Wire and Rendezvous PtcaDQO · Traditional | 10/06/1992SE |
| K922410 | Scimed Avenue Coronary Guidewire Insertion ToolDQX · Traditional | 07/23/1992SE |
| K914194 | Scimed(R) Controlwire(Tm) Guide WireDQX · Traditional | 06/09/1992SE |
| K914312 | Scimed 7FR and 8FR Triguide Guiding CathetersDQO · Traditional | 11/22/1991SE |
| K913830 | Scimed 8 Fr. Triguideflex Guiding CathetersDQY · Traditional | 11/22/1991SE |
| K913364 | Scimed 7 Fr. & 8 Fr.DQO · Traditional | 08/30/1991SE |
| K911870 | Scimed Optamum Operative Peripheral Angioplas CathLIT · Traditional | 08/12/1991SE |
| K905499 | Scimd 7 Fr. Triguide Guiding CatheterDQO · Traditional | 02/11/1991SE |
| K910155 | Scimed Optamum Oper Peripheral Angioplasty CathLIT · Traditional | 02/07/1991SE |
| K895437 | Scimed Coronary Guiding CatheterDQO · Traditional | 06/28/1990SE |
| K896108 | The Pilot Scimed Torque DeviceLOX · Traditional | 01/09/1990SE |
| K894103 | Scimed Ultrox True Membrane Oxygen Syst, Ultrox IIDTZ · Traditional | 09/21/1989SE |
| K884560 | Scimed Ecmotherm(Tm) Heat ExchangerDTR · Traditional | 04/03/1989SE |
| K882380 | Scimed Model Sm-C/Vr Cardiotomy/Venous ReservoirDTN · Traditional | 10/06/1988SE |
| K883054 | Scimed Ultrox True Membrane Oxy. Ultrox I & IIDTZ · Traditional | 09/26/1988SE |
| K883053 | Scimed Membrane Oxygenator, Model 0600-2ADTZ · Traditional | 09/26/1988SE |
| K882720 | Scimed R30 Silicone Assist ReservoirDTN · Traditional | 09/16/1988SE |
| K880451 | Scimed Models P-7-14 and A-19-38 Heat ExchangersDTR · Traditional | 04/28/1988SE |
| K875064 | Scimed Inflation Device, Model SM 2000LIT · Traditional | 02/29/1988SE |
| K863476 | Scimed Membrane Oxygenator System - EcmoDTZ · Traditional | 11/25/1986SE |
| K862918 | Scimed II-SM25 Membrane Oxygenator SystemDTZ · Traditional | 09/23/1986SE |
| K855049 | Modified Model SC4000(F) Cardiotomy ReservoirDTP · Traditional | 02/26/1986SE |
| K850760 | Mills Operative Peripheral Angioplasty CatheterLIT · Traditional | 04/10/1985SE |
| K850075 | Scimed Percutaneous Transluminal Angioplasty DilatLIT · Traditional | 04/10/1985SE |
| K843956 | Scimed II Membrane Oxygenator SystemDTZ · Traditional | 01/08/1985SE |
| K843448 | Scimed PM200 Inflation ManometerMAV · Traditional | 10/23/1984SE |
| K841961 | Mills Operative Peripheral AngioplastyLIT · Traditional | 10/23/1984SE |
| K840610 | Scimed Model SC4000DTP · Traditional | 04/24/1984SE |
| K834041 | Cardiotomy Reservoir SC3500FDTP · Traditional | 01/30/1984SE |
| K831528 | Model TP Thermistor ProbeDRF · Traditional | 06/30/1983SE |
| K831261 | Sci Med Tubing ConnectorsDTL · Traditional | 06/03/1983SE |
| K831260 | Sci Med Temperature Monitoring AdaptorDTL · Traditional | 06/03/1983SE |
| K820954 | Scimed Model SC 3000DTP · Traditional | 05/24/1982SE |
| K813268 | SC-2500F Cardiotomy ReserviorDTN · Traditional | 05/18/1982SE |
| K791792 | Sci Med Pericardial SubstituteDXZ · Traditional | 12/07/1979SE |
| K772117 | Heat Exchanger, Disp., OmnithermDTR · Traditional | 03/02/1978SE |
| K770681 | Valve, Pressure Relief, Blood OxygenatorKRI · Traditional | 04/26/1977SE |