Product code KRI
- Device name
- Accessory Equipment, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Device class
- 1
- Regulation number
- 870.4200
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K020365 | 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE | 3t Medical Systems, LLC | 2002-05-03 |
| K992635 | INTERFACE MODULE IDDD | Stoeckert Instrumente | 1999-12-20 |
| K990512 | STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS | Stoeckert Instrumente | 1999-11-23 |
| K934782 | AMMEX TUBING ORGANIZER | Ammex Cardiopulmonary Corp. | 1993-11-18 |
| K926233 | CARDIO2 CYCLE | Ergometrix, Inc. | 1993-06-04 |
| K922404 | TUBE GRIP | Georgia Medical Products, Inc. | 1992-11-23 |
| K892856 | NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS | Acacia Laboratories, Inc. | 1989-11-08 |
| K884893 | CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 | American Omni Medical, Inc. | 1989-01-30 |
| K884640 | CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 | American Omni Medical, Inc. | 1989-01-24 |
| K874605 | HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR | Mallinckrodt Critical Care | 1988-02-02 |
| K874925 | CPE 2000 CARDIO PULMONARY ERGOMETER | Medical Graphics Corp. | 1988-01-19 |
| K864890 | STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP | Shiley, Inc. | 1987-02-19 |
| K862510 | STOCKERT-SHILEY CAPS 4 CHANNEL TEMP. MONITOR 1 | Shiley, Inc. | 1986-07-17 |
| K862549 | ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE | American Bentley | 1986-07-15 |
| K860298 | STABLELINE | Cardio Metrics, Inc. | 1986-04-02 |
| K860672 | ADJUSTABLE OXYGENATOR HOLDER MODEL NO. BCM-HL | American Bentley | 1986-03-03 |
| K854113 | CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH | American Bentley | 1986-01-08 |
| K852455 | GAMBRO DIGITAL TELETHERMOMETER TTH 10-200 | Gambro, Inc. | 1985-09-16 |
| K851077 | CARDIAC COOLING JACKET | Pat O. Daily | 1985-07-11 |
| K851289 | COBE GAS FILTER | Cobe Laboratories, Inc. | 1985-06-19 |
| K841812 | HOLDER FOR BOS-10, 10S 5S | American Bentley | 1984-06-11 |
| K841296 | TUBE TENDER | The Anspach Effort, Inc. | 1984-06-11 |
| K841032 | HOLDER FOR MODELS AF-10,1025,1040,5 | American Bentley | 1984-04-17 |
| K832704 | SHILEY GAS FILTER | Shiley, Inc. | 1983-09-29 |
| K832411 | GASLINE FILTER #GF-10 | American Bentley | 1983-09-12 |
| K830167 | HOLDER FOR BOS-2S INFANT BUBBLE OXYGENA- | American Bentley | 1983-03-11 |
| K822097 | D645-BACTERIOLOGICAL GAS LINE FILTER | Electromedics, Inc. | 1982-07-30 |
| K820406 | TMO INTEGRATED CIRCUIT SYSTEM | Travenol Laboratories, S.A. | 1982-03-02 |
| K813271 | TEMPERATURE PROBES | Webster Laboratories, Inc. | 1981-12-29 |
| K811368 | CARDIOPLEGIA COOLING & ADMIN. SETS | Bentley Laboratories, Inc. | 1981-06-09 |
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| 08052595517458 | HOLDER | EUROSETS SRL | 2026-05-05 |
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| B066332022NS1 | "CONNECTOR, 1/4"" X 1/4"" W/LUER" | NOVOSCI CORP. | 2015-10-13 |
| B066332012NS1 | "CONNECTOR, 3/16"" X 1/4"" W/OUT PART LINE W/LUER" | NOVOSCI CORP. | 2015-10-13 |
| B0663320120000 | "CONNECTOR, 3/16"" X 1/4"" W/OUT PART LINE W/LUER" | NOVOSCI CORP. | 2015-10-13 |
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| B066331044NS1 | "CONNECTOR, 1/2"" X 1/2"" W/OUT PART LINE" | NOVOSCI CORP. | 2015-10-13 |
| B066331034NS1 | "CONNECTOR, 3/8"" X 1/2"" W/OUT PART LINE" | NOVOSCI CORP. | 2015-10-13 |
| B066331033NS1 | "CONNECTOR, 3/8"" X 3/8"" W/OUT PART LINE" | NOVOSCI CORP. | 2015-10-13 |
| B066331024NS1 | "CONNECTOR, 1/4"" X 1/2"" W/OUT LUER " | NOVOSCI CORP. | 2015-10-13 |
| B066331023NS1 | "CONNECTOR, 1/4"" X 3/8"" W/OUT PART LINE" | NOVOSCI CORP. | 2015-10-13 |
| B066331022NS1 | "CONNECTOR, 1/4"" X 1/4"" W/OUT PART LINE" | NOVOSCI CORP. | 2015-10-13 |
| B066331012NS1 | "CONNECTOR, 3/16"" X 1/4"" W/OUT PART LINE" | NOVOSCI CORP. | 2015-10-13 |
| B066331011NS1 | "CONNECTOR, 3/16"" X 3/16"" W/OUT PART LINE " | NOVOSCI CORP. | 2015-10-13 |
| B066311033NS1 | TUBING ORGANIZER - NON-STERILE | NOVOSCI CORP. | 2015-10-13 |
| B0663310240000 | "CONNECTOR, 1/4"" X 1/2"" W/OUT PART LINE" | NOVOSCI CORP. | 2015-10-12 |
| B0663310230000 | "CONNECTOR, 1/4"" X 3/8"" W/OUT PART LINE" | NOVOSCI CORP. | 2015-10-12 |
| B0663310340000 | "CONNECTOR, 3/8"" X 1/2"" W/OUT PART LINE" | NOVOSCI CORP. | 2015-10-12 |
| B0663310440000 | "CONNECTOR, 1/2"" X 1/2"" W/OUT PART LINE" | NOVOSCI CORP. | 2015-10-12 |
| B0663310220000 | "CONNECTOR, 1/4"" X 1/4"" W/OUT PART LINE" | NOVOSCI CORP. | 2015-10-12 |
| B0663310120000 | "CONNECTOR, 3/16"" X 1/4"" W/OUT PART LINE" | NOVOSCI CORP. | 2015-10-12 |
| B0663310110000 | "CONNECTOR, 3/16"" X 3/16"" W/OUT PART LINE" | NOVOSCI CORP. | 2015-10-12 |
| B0663310330000 | "CONNECTOR, 3/8"" X 3/8"" W/OUT PART LINE" | NOVOSCI CORP. | 2015-10-07 |
| B0663110330000 | TUBING ORGANIZER - STERILE | NOVOSCI CORP. | 2015-10-06 |