FDA Product Code
FDA Product Code KRI — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4200
510(k) Clearances — 42 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K020365 | 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE | 3t Medical Systems, LLC | 2002-05-03 | Traditional | PDF ↗ |
| K992635 | INTERFACE MODULE IDDD | Stoeckert Instrumente | 1999-12-20 | Special | PDF ↗ |
| K990512 | STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS | Stoeckert Instrumente | 1999-11-23 | Traditional | PDF ↗ |
| K934782 | AMMEX TUBING ORGANIZER | Ammex Cardiopulmonary Corp. | 1993-11-18 | Traditional | PDF ↗ |
| K926233 | CARDIO2 CYCLE | Ergometrix, Inc. | 1993-06-04 | Traditional | PDF ↗ |
| K922404 | TUBE GRIP | Georgia Medical Products, Inc. | 1992-11-23 | Traditional | PDF ↗ |
| K892856 | NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS | Acacia Laboratories, Inc. | 1989-11-08 | Traditional | PDF ↗ |
| K884893 | CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 | American Omni Medical, Inc. | 1989-01-30 | Traditional | PDF ↗ |
| K884640 | CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 | American Omni Medical, Inc. | 1989-01-24 | Traditional | PDF ↗ |
| K874605 | HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR | Mallinckrodt Critical Care | 1988-02-02 | Traditional | PDF ↗ |
| K874925 | CPE 2000 CARDIO PULMONARY ERGOMETER | Medical Graphics Corp. | 1988-01-19 | Traditional | PDF ↗ |
| K864890 | STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP | Shiley, Inc. | 1987-02-19 | Traditional | PDF ↗ |
| K862510 | STOCKERT-SHILEY CAPS 4 CHANNEL TEMP. MONITOR 1 | Shiley, Inc. | 1986-07-17 | Traditional | PDF ↗ |
| K862549 | ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE | American Bentley | 1986-07-15 | Traditional | PDF ↗ |
| K860298 | STABLELINE | Cardio Metrics, Inc. | 1986-04-02 | Traditional | PDF ↗ |
| K860672 | ADJUSTABLE OXYGENATOR HOLDER MODEL NO. BCM-HL | American Bentley | 1986-03-03 | Traditional | PDF ↗ |
| K854113 | CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH | American Bentley | 1986-01-08 | Traditional | PDF ↗ |
| K852455 | GAMBRO DIGITAL TELETHERMOMETER TTH 10-200 | Gambro, Inc. | 1985-09-16 | Traditional | PDF ↗ |
| K851077 | CARDIAC COOLING JACKET | Pat O. Daily | 1985-07-11 | Traditional | PDF ↗ |
| K851289 | COBE GAS FILTER | Cobe Laboratories, Inc. | 1985-06-19 | Traditional | PDF ↗ |
| K841812 | HOLDER FOR BOS-10, 10S 5S | American Bentley | 1984-06-11 | Traditional | PDF ↗ |
| K841296 | TUBE TENDER | The Anspach Effort, Inc. | 1984-06-11 | Traditional | PDF ↗ |
| K841032 | HOLDER FOR MODELS AF-10,1025,1040,5 | American Bentley | 1984-04-17 | Traditional | PDF ↗ |
| K832704 | SHILEY GAS FILTER | Shiley, Inc. | 1983-09-29 | Traditional | PDF ↗ |
| K832411 | GASLINE FILTER #GF-10 | American Bentley | 1983-09-12 | Traditional | PDF ↗ |
| K830167 | HOLDER FOR BOS-2S INFANT BUBBLE OXYGENA- | American Bentley | 1983-03-11 | Traditional | PDF ↗ |
| K822097 | D645-BACTERIOLOGICAL GAS LINE FILTER | Electromedics, Inc. | 1982-07-30 | Traditional | PDF ↗ |
| K820406 | TMO INTEGRATED CIRCUIT SYSTEM | Travenol Laboratories, S.A. | 1982-03-02 | Traditional | PDF ↗ |
| K813271 | TEMPERATURE PROBES | Webster Laboratories, Inc. | 1981-12-29 | Traditional | PDF ↗ |
| K811368 | CARDIOPLEGIA COOLING & ADMIN. SETS | Bentley Laboratories, Inc. | 1981-06-09 | Traditional | PDF ↗ |
| K811348 | CARDIOPULMONARY BYPASS ACCESSORY EQUIP. | Bentley Laboratories, Inc. | 1981-05-29 | Traditional | PDF ↗ |
| K810079 | SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS | 3M Health Care, Sarns | 1981-01-30 | Traditional | PDF ↗ |
| K802539 | DISPOSABLE GAS LINE FILTER | Texas Medical Products, Inc. | 1981-01-16 | Traditional | PDF ↗ |
| K802542 | DISPOSABLE CONNECTORS | Texas Medical Products, Inc. | 1981-01-16 | Traditional | PDF ↗ |
| K802541 | DISPOSABLE PARALLEL Y CONNECTORS | Texas Medical Products, Inc. | 1981-01-16 | Traditional | PDF ↗ |
| K802906 | WILLIAM HARVEY OXYGENATING GAS FILTER | C.R. Bard, Inc. | 1980-12-16 | Traditional | PDF ↗ |
| K792151 | OXYGENATOR GAS LINE FILTER | Cardio Systems, Inc. | 1979-11-13 | Traditional | PDF ↗ |
| K791829 | SHILEY QUICK DISCONNECT ASSEMBLY | Shiley, Inc. | 1979-10-02 | Traditional | PDF ↗ |
| K790192 | SARNO SINGLE POLE MAST | Sames, Inc. | 1979-02-08 | Traditional | PDF ↗ |
| K781861 | FILTER, EXTRACORPOREAL BLOOD HOLDER | Surgikos, Inc. | 1978-11-15 | Traditional | PDF ↗ |
| K780984 | PVC QUICK PRIME LINES | Norton Performance Plastics Corp. | 1978-07-17 | Traditional | PDF ↗ |
| K770681 | VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR | Scimed Life Systems, Inc. | 1977-04-26 | Traditional | PDF ↗ |
Product code KRI · Class I · Cardiovascular. Data: openFDA.