Bentley Laboratories, Inc.
Medical device manufacturer in Irvine, CA.
55510(k) clearances
0PMA approvals
0recalls
Device types
- DTZ Oxygenator, Cardiopulmonary Bypass 10
- DTN Reservoir, Blood, Cardiopulmonary Bypass 6
- DTM Filter, Blood, Cardiopulmonary Bypass… 6
- DXY Implantable Pacemaker Pulse-Generator 4
- DRS Transducer, Blood-Pressure, Extravascular 4
- KRA Catheter, Continuous Flush 2
- FJI Dialyzer, Capillary, Hollow Fiber 2
- KRJ Filter, Prebypass, Cardiopulmonary Bypass 2
- KDI Dialyzer, High Permeability With Or Without… 2
- DTR Heat-Exchanger, Cardiopulmonary Bypass 2
- KRI Accessory Equipment, Cardiopulmonary Bypass 2
- KRB Probe, Thermodilution 1
- KPI Stimulator, Electrical, Non-Implantable… 1
- KOC Accessories, Blood Circuit, Hemodialysis 1
- KDQ Bottle, Collection, Vacuum 1
- FIQ Cannula, A-V Shunt 1
- DWF Catheter, Cannula And Tubing, Vascular… 1
- DXC Clamp, Vascular 1
- CAK Microfilter, Blood Transfusion 1
- FHS Dialyzer, Single Coil 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K931967 | HE-30 GoldDTR · Traditional | 07/13/1993SE |
| K913956 | Blood Cardioplegia Heat Exchanger, Model #HE-30DTN · Traditional | 01/17/1992SE |
| K913692 | Venous Reservoir Bag Model No. BMR-250(TM)DTN · Traditional | 11/15/1991SE |
| K903641 | Quick Prime Hemoconcen. No. HQ-7000 and CBP-7000QKDI · Traditional | 11/09/1990SE |
| K894826 | Univox W/Holders, Models Univox-Hl, HLB, HLFDTZ · Traditional | 02/28/1990SE |
| K874867 | Catr(Tm)-H Cardiotomy HolderKPI · Traditional | 02/02/1988SE |
| K874841 | Integrated Membrane Oxygenator W/Cardiotomy FilterDTZ · Traditional | 02/02/1988SE |
| K874618 | Baxter Accuport(Tm) Central Venous CatheterDQR · Traditional | 01/19/1988SE |
| K823359 | Oxygen Consumption Monitor #OCM-0100DRY · Traditional | 01/05/1983SE |
| K823273 | BOS-2S, Spiraflo Bubble Infant Oxygen.DTZ · Traditional | 01/05/1983SE |
| K823456 | Oxygenators #BOS-10, 105, 5SDTZ · Traditional | 12/30/1982SE |
| K823272 | Venous Reservoir Bag #BMR-1400DTN · Traditional | 12/30/1982SE |
| K822803 | Blood Oxygenators #BOS-105S BOS-5S W/DTZ · Traditional | 11/01/1982SE |
| K821416 | Disposable Blood Pressure TransducerDRS · Traditional | 07/02/1982SE |
| K820044 | Arterial Blood Filter, #AF-1025DTM · Traditional | 06/29/1982SE |
| K820679 | Pediatric Arterial Blood Filter #AF-540DTM · Traditional | 06/17/1982SE |
| K820343 | Arterial Blood Filter Model #AF-1040DTM · Traditional | 06/17/1982SE |
| K821495 | Disposable Blood Line ConnectorsKOC · Traditional | 05/27/1982SE |
| K820243 | Continuous Blood Processor CBP-6000 &KDI · Traditional | 03/25/1982SE |
| K820342 | Physiological Pressure Transducer #900DRS · Traditional | 03/04/1982SE |
| K820046 | Anesthesiology DevicesDRS · Traditional | 01/29/1982SE |
| K820045 | Cardiovascular DevicesDTM · Traditional | 01/29/1982SE |
| K813053 | Disposable Blood Pressure Transducer DomDRS · Traditional | 11/16/1981SE |
| K812224 | Pleural Drainage System #PDS-4300KDQ · Traditional | 09/09/1981SE |
| K812173 | Flushflo IIKRA · Traditional | 08/18/1981SE |
| K812009 | Cardiotomy Reservoir W/FILTER#BCR-3500DTN · Traditional | 07/28/1981SE |
| K812008 | Cordiotomy ReservoirDTN · Traditional | 07/28/1981SE |
| K811368 | Cardioplegia Cooling & Admin. SetsKRI · Traditional | 06/09/1981SE |
| K811348 | Cardiopulmonary Bypass Accessory Equip.KRI · Traditional | 05/29/1981SE |
| K810114 | Vascular Access SystemFIQ · Traditional | 03/26/1981SE |
| K802847 | Oxygen Saturation Meter Model No. SM-1 · Traditional | 12/16/1980SE |
| K802720 | Spiraflo Blood Oxygenators Model BOS-5SDTZ · Traditional | 12/16/1980SE |
| K802719 | Spiraflo Blood Oxygenators Model BOS-10SDTZ · Traditional | 12/16/1980SE |
| K802848 | Cardioplegia Cooling Syst. CCAS-2DTR · Traditional | 12/11/1980SE |
| K802378 | Quick Prime Lines, #'S BPL-12, BPL-48 &DWF · Traditional | 10/10/1980SE |
| K802244 | Vessel Retractor, #600732DXC · Traditional | 10/03/1980SE |
| K801640 | Sorin Pulse Generator, Model #LIT-214DXY · Traditional | 10/03/1980SE |
| K802133 | Bentley Theromodilution Catheter #BTD-7FKRB · Traditional | 09/26/1980SE |
| K801240 | Built-In Temperature MonitoringDTZ · Traditional | 06/04/1980SE |
| K801147 | Pediatric Arterial Blood Filter #AF-5DTM · Traditional | 06/04/1980SE |
| K792565 | Sorin Pulse Generator Model # Lit 214 HDXY · Traditional | 02/05/1980SE |
| K792526 | Pulse Generator, Model No. Lit 222DXY · Traditional | 02/05/1980SE |
| K800135 | Cardioplegia Administration System CasKRJ · Traditional | 02/01/1980SE |
| K792450 | Arterial Blood Filter, Model AF-10DTM · Traditional | 12/19/1979SE |
| K790308 | Disposable Dialyzers, Sd-Id, SD-2DFJI · Traditional | 05/01/1979SE |
| K790635 | Q220F Carditomy Reservoir/ModifiedDTN · Traditional | 04/18/1979SE |
| K790361 | Recirculation Filter Model RF-10KRJ · Traditional | 03/28/1979SE |
| K780897 | Generator, Pulse, Sorin Model DL-1DXY · Traditional | 12/06/1978SE |
| K781842 | Oxygenator, Blood BOS-10DTZ · Traditional | 11/08/1978SE |
| K780078 | Oxygenator, Bubble TypeDTZ · Traditional | 09/14/1978SE |
| K772423 | Spiraflow DialyzersFJI · Traditional | 01/26/1978SE |
| K761273 | Flushflo-Model CC1-6KRA · Traditional | 01/12/1977SE |
| K761358 | Coil Dialyzer Model Alt 140FHS · Traditional | 01/10/1977SE |
| K760797 | Spiraflo Dialyzer, DisposableEJT · Traditional | 11/19/1976SE |
| K760165 | Filter, Infusion Blood (1 PFF-100)CAK · Traditional | 08/06/1976SE |