Company ยท US
American Bentley
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 1988. Name variants (Inc, Corp, punctuation) are merged.
59510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | 13 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 11 |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | 7 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 5 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 4 |
| CCE | Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling | 3 |
| DRS | Transducer, Blood-Pressure, Extravascular | 3 |
| DTP | Defoamer, Cardiopulmonary Bypass | 2 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 |
| CAC | Apparatus, Autotransfusion | 1 |
| CCC | Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling | 1 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 1 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 |
| DXO | Transducer, Pressure, Catheter Tip | 1 |
| FKI | Set, Dialyzer Holder | 1 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 12, 1988 | K872896 | UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100 American Bentley | CCE |
| Nov 6, 1987 | K873923 | INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER American Bentley | DTZ |
| Sep 1, 1987 | K872167 | CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500 American Bentley | DTP |
| Sep 1, 1987 | K870804 | CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100 American Bentley | DTR |
| Aug 24, 1987 | K872133 | OXYGENATOR MODEL NO. BENTLEY 5 PLUS American Bentley | DTZ |
| May 29, 1987 | K870911 | INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY American Bentley | CCC |
| Mar 9, 1987 | K870269 | ELECTROSURGICAL MENISCUS CUTTER (EMC) MOD. AMC-100 American Bentley | GEI |
| Oct 20, 1986 | K863249 | OXYGENATOR MODEL NO. BENTLEY-10 PLUS American Bentley | DTZ |
| Sep 29, 1986 | K861641 | HEPARIN-COATED EXTRACORPOREAL CIRCUITS American Bentley | DTZ |
| Jul 15, 1986 | K862549 | ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE American Bentley | KRI |
| Jun 26, 1986 | K860673 | OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B American Bentley | DTZ |
| Mar 3, 1986 | K860672 | ADJUSTABLE OXYGENATOR HOLDER MODEL NO. BCM-HL American Bentley | KRI |
| Feb 26, 1986 | K860106 | OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100 American Bentley | CCE |
| Jan 8, 1986 | K854113 | CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH American Bentley | KRI |
| Dec 16, 1985 | K854045 | MEMBRANE OXYGENATING SYS ADULT BMOS-7 & BMOS-3 PED American Bentley | DTZ |
| Dec 11, 1985 | K853950 | ARTERIAL/VENOUS SAMPLE LINE BOS-CMSL American Bentley | DTL |
| Oct 16, 1985 | K853786 | OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100 American Bentley | CCE |
| Sep 25, 1985 | K852382 | CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR American Bentley | DTN |
| Sep 16, 1985 | K852124 | HEMATOCRIT-SATURATION MONITOR HSM-100 American Bentley | DRY |
| Sep 9, 1985 | K841811 | BENTLEY-TRANTEC DISPOS. DOMES D-260- American Bentley | DRS |
| Aug 12, 1985 | K852683 | ELECTROSURGICAL LATERAL RELEASE PROBE MOD ALR-100 American Bentley | GEI |
| Jun 25, 1985 | K851401 | VENUOS RESERVOIR BAG BMR-1900 American Bentley | DTN |
| Jun 25, 1985 | K851376 | VENOUS RESERVOIR BAG BMR-1600 American Bentley | DTN |
| Jun 11, 1985 | K833047 | DOSIMETRIC RELEASE OF RAD. TUBING PAC American Bentley | DWF |
| May 21, 1985 | K850925 | BLOOD TUBING(PVC) 201458 W/(TOTM) PLASTICIZER American Bentley | DWF |
| May 16, 1985 | K851035 | AMERICAN BENTLEY OXYGENATOR MAX-2 American Bentley | DTZ |
| Mar 27, 1985 | K850630 | BLOOD OXYGENATOR MODEL NO. MAX-5 American Bentley | DTZ |
| Mar 7, 1985 | K844901 | AMER. BENTLEY OXYGENATOR MAX-10 W/SMOOTH HEAT EXCH American Bentley | DTZ |
| Jan 14, 1985 | K844367 | CARDIOTOMY RESERVOIR W/FILTER BCR-2500 American Bentley | DTN |
| Jan 14, 1985 | K844366 | CARDIOTOMY RESERVOIR BCR-2000 American Bentley | DTN |
| Jan 8, 1985 | K842813 | HEPARIN COATED ARTERIAL BLOOD FILTERS American Bentley | DTM |
| Dec 27, 1984 | K842373 | VENOUS RESERVOIR-BMR-1500-HARD SHELL American Bentley | DTP |
| Oct 18, 1984 | K843504 | AMER. BENTLEY HEMOFILTER HOLDER HFH-1 American Bentley | FKI |
| Oct 18, 1984 | K841585 | AMER. BENTLEY CONTINU-BLOOD PROCESSOR- American Bentley | KDI |
| Aug 27, 1984 | K842620 | CARDIOTOMY RESERVOIR W/FILTER BCR-3500 American Bentley | DTN |
| Aug 3, 1984 | K841938 | CARDIOPLEGIA RESERVOIR CAS-2000 American Bentley | DTN |
| Aug 3, 1984 | K841476 | TUBULAR HOLLOW FIBER MEMBRANE American Bentley | DTZ |
| Jun 22, 1984 | K840023 | TRANTEC PHYSIOLOGICAL PRESSURE TRANSDUC American Bentley | DRS |
| Jun 11, 1984 | K841812 | HOLDER FOR BOS-10, 10S 5S American Bentley | KRI |
| May 23, 1984 | K841031 | OXYHI CRYSTALLOID CARDIOPLEGIA SOLUT American Bentley | DTN |
| Apr 17, 1984 | K841032 | HOLDER FOR MODELS AF-10,1025,1040,5 American Bentley | KRI |
| Apr 17, 1984 | K840612 | PEDIATRIC ARTERIAL BLOOD FILTER American Bentley | DTM |
| Feb 17, 1984 | K840256 | CARDIOPLEGIA HEAT EXCHANGER HOLDER American Bentley | DTR |
| Feb 13, 1984 | K840045 | CARDIOPLEGIA HEAT EXCHANGER HE-100 American Bentley | DTR |
| Feb 10, 1984 | K833792 | TRANTECSILICONE QUARTZ DISP. TRANSD American Bentley | DRS |
| Feb 4, 1984 | K834373 | CARDIOTOMY RESERVORS BCR-3000/3500-Q-120 American Bentley | DTN |
| Jan 3, 1984 | K833670 | BOS-CM40,50 HOLDER & RESERVOIR BAG American Bentley | DTZ |
| Dec 29, 1983 | K833518 | BLOOD OXYGENATOR HEAT EXHANGER COATING American Bentley | DTZ |
| Dec 29, 1983 | K832802 | USE OF TWEEN 80 AS A WETTING AGENT ON American Bentley | DTN |
| Dec 29, 1983 | K831849 | PLEURAL DRAINAGE SYS #PDS-100-4 American Bentley | CAC |
Newest 50 of 59.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||