American Bentley
Medical device manufacturer in Irvine, CA.
59510(k) clearances
0PMA approvals
0recalls
Device types
- DTZ Oxygenator, Cardiopulmonary Bypass 13
- DTN Reservoir, Blood, Cardiopulmonary Bypass 11
- KRI Accessory Equipment, Cardiopulmonary Bypass 7
- DTM Filter, Blood, Cardiopulmonary Bypass… 5
- DTR Heat-Exchanger, Cardiopulmonary Bypass 4
- DRS Transducer, Blood-Pressure, Extravascular 3
- CCE Analyzer, Gas, Oxygen, Partial Pressure… 3
- DTP Defoamer, Cardiopulmonary Bypass 2
- DWF Catheter, Cannula And Tubing, Vascular… 2
- GEI Electrosurgical, Cutting & Coagulation &… 2
- CCC Analyzer, Gas, Carbon-Dioxide, Partial… 1
- DTL Adaptor, Stopcock, Manifold, Fitting… 1
- DRY Monitor, Blood-Gas, On-Line… 1
- FKI Set, Dialyzer Holder 1
- KDI Dialyzer, High Permeability With Or Without… 1
- CAC Apparatus, Autotransfusion 1
- DXO Transducer, Pressure, Catheter Tip 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K872896 | Umbilical Artery Oxygen Probe Model UAP-100CCE · Traditional | 02/12/1988SE |
| K873923 | Integrated Membrane Oxygenator W/Cardiotomy FilterDTZ · Traditional | 11/06/1987SE |
| K872167 | Cardiotomy/Mediastinal Auto. Reservoir CATR-3500DTP · Traditional | 09/01/1987SE |
| K870804 | Cardioplegia Heat Exchanger Model No. HE-100DTR · Traditional | 09/01/1987SE |
| K872133 | Oxygenator Model No. Bentley 5 PlusDTZ · Traditional | 08/24/1987SE |
| K870911 | Indwelling Blood Carbondioxide Partial Pres. AnalyCCC · Traditional | 05/29/1987SE |
| K870269 | Electrosurgical Meniscus Cutter (Emc) Mod. AMC-100GEI · Traditional | 03/09/1987SE |
| K863249 | Oxygenator Model No. BENTLEY-10 PlusDTZ · Traditional | 10/20/1986SE |
| K861641 | Heparin-Coated Extracorporeal CircuitsDTZ · Traditional | 09/29/1986SE |
| K862549 | Arterial Blood Filter Holder Model No. Af-HeKRI · Traditional | 07/15/1986SE |
| K860673 | Oxygenator Model Nos. BENTLEY-10A & BENTLEY-10BDTZ · Traditional | 06/26/1986SE |
| K860672 | Adjustable Oxygenator Holder Model No. Bcm-HlKRI · Traditional | 03/03/1986SE |
| K860106 | Oxygen Monitor No. OM-100, Oxygen Probe No. OP-100CCE · Traditional | 02/26/1986SE |
| K854113 | Cardioplegia Heat Exchanger Holder HE-100SHKRI · Traditional | 01/08/1986SE |
| K854045 | Membrane Oxygenating Sys Adult BMOS-7 & BMOS-3 PedDTZ · Traditional | 12/16/1985SE |
| K853950 | Arterial/Venous Sample Line Bos-CmslDTL · Traditional | 12/11/1985SE |
| K853786 | Oxygen Monitor OM-100 & Oxygen Probe OP-100CCE · Traditional | 10/16/1985SE |
| K852382 | Cardiotomy/Mediastinal Autotransfusion ReservoirDTN · Traditional | 09/25/1985SE |
| K852124 | Hematocrit-Saturation Monitor HSM-100DRY · Traditional | 09/16/1985SE |
| K841811 | Bentley-Trantec Dispos. Domes D-260-DRS · Traditional | 09/09/1985SE |
| K852683 | Electrosurgical Lateral Release Probe Mod ALR-100GEI · Traditional | 08/12/1985SE |
| K851401 | Venuos Reservoir Bag BMR-1900DTN · Traditional | 06/25/1985SE |
| K851376 | Venous Reservoir Bag BMR-1600DTN · Traditional | 06/25/1985SE |
| K833047 | Dosimetric Release of Rad. Tubing PacDWF · Traditional | 06/11/1985SE |
| K850925 | Blood Tubing(Pvc) 201458 W/(Totm) PlasticizerDWF · Traditional | 05/21/1985SE |
| K851035 | American Bentley Oxygenator MAX-2DTZ · Traditional | 05/16/1985SE |
| K850630 | Blood Oxygenator Model No. MAX-5DTZ · Traditional | 03/27/1985SE |
| K844901 | Amer. Bentley Oxygenator MAX-10 W/Smooth Heat ExchDTZ · Traditional | 03/07/1985SE |
| K844367 | Cardiotomy Reservoir W/Filter BCR-2500DTN · Traditional | 01/14/1985SE |
| K844366 | Cardiotomy Reservoir BCR-2000DTN · Traditional | 01/14/1985SE |
| K842813 | Heparin Coated Arterial Blood FiltersDTM · Traditional | 01/08/1985SE |
| K842373 | Venous RESERVOIR-BMR-1500-HARD ShellDTP · Traditional | 12/27/1984SE |
| K843504 | Amer. Bentley Hemofilter Holder HFH-1FKI · Traditional | 10/18/1984SE |
| K841585 | Amer. Bentley Continu-Blood Processor-KDI · Traditional | 10/18/1984SE |
| K842620 | Cardiotomy Reservoir W/Filter BCR-3500DTN · Traditional | 08/27/1984SE |
| K841938 | Cardioplegia Reservoir CAS-2000DTN · Traditional | 08/03/1984SE |
| K841476 | Tubular Hollow Fiber MembraneDTZ · Traditional | 08/03/1984SE |
| K840023 | Trantec Physiological Pressure TransducDRS · Traditional | 06/22/1984SE |
| K841812 | Holder for BOS-10, 10S 5SKRI · Traditional | 06/11/1984SE |
| K841031 | Oxyhi Crystalloid Cardioplegia SolutDTN · Traditional | 05/23/1984SE |
| K841032 | Holder for Models AF-10,1025,1040,5KRI · Traditional | 04/17/1984SE |
| K840612 | Pediatric Arterial Blood FilterDTM · Traditional | 04/17/1984SE |
| K840256 | Cardioplegia Heat Exchanger HolderDTR · Traditional | 02/17/1984SE |
| K840045 | Cardioplegia Heat Exchanger HE-100DTR · Traditional | 02/13/1984SE |
| K833792 | Trantecsilicone Quartz Disp. TransdDRS · Traditional | 02/10/1984SE |
| K834373 | Cardiotomy Reservors BCR-3000/3500-Q-120DTN · Traditional | 02/04/1984SE |
| K833670 | BOS-CM40,50 Holder & Reservoir BagDTZ · Traditional | 01/03/1984SE |
| K833518 | Blood Oxygenator Heat Exhanger CoatingDTZ · Traditional | 12/29/1983SE |
| K832802 | Use of Tween 80 AS a Wetting Agent onDTN · Traditional | 12/29/1983SE |
| K831849 | Pleural Drainage Sys #PDS-100-4CAC · Traditional | 12/29/1983SE |
| K832384 | BP Transducer Holders TH-2,3 & 4DXO · Traditional | 11/14/1983SE |
| K833048 | Purges Lines, PL-45 & PL-33DTM · Traditional | 10/20/1983SE |
| K832411 | Gasline Filter #GF-10KRI · Traditional | 09/12/1983SE |
| K831966 | Cardioplegia RESERVOIR-#500926DTN · Traditional | 08/11/1983SE |
| K831157 | Blood Cardioplegia Stainless Steel CoolDTR · Traditional | 05/09/1983SE |
| K830327 | Dosimetric Release of Radiation DevDTZ · Traditional | 03/24/1983SE |
| K830167 | Holder for BOS-2S Infant Bubble Oxygena-KRI · Traditional | 03/11/1983SE |
| K830132 | Arterial Blood Filter AF-1040-AF-1040BLDTM · Traditional | 01/28/1983SE |
| K830131 | Arterial Blood Filter AF-1025-AF-1025BLDTM · Traditional | 01/28/1983SE |