KRI — Accessory Equipment, Cardiopulmonary Bypass Class I
FDA Device Classification
Classification Details
- Product Code
- KRI
- Device Class
- Class I
- Regulation Number
- 870.4200
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K020365 | 3t medical systems | 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE | May 3, 2002 |
| K992635 | stoeckert instrumente | INTERFACE MODULE IDDD | December 20, 1999 |
| K990512 | stoeckert instrumente | STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS | November 23, 1999 |
| K934782 | ammex cardiopulmonary | AMMEX TUBING ORGANIZER | November 18, 1993 |
| K926233 | ergometrix | CARDIO2 CYCLE | June 4, 1993 |
| K922404 | georgia medical products | TUBE GRIP | November 23, 1992 |
| K892856 | acacia laboratories | NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS | November 8, 1989 |
| K884893 | american omni medical | CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 | January 30, 1989 |
| K884640 | american omni medical | CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 | January 24, 1989 |
| K874605 | mallinckrodt critical care | HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR | February 2, 1988 |
| K874925 | medical graphics | CPE 2000 CARDIO PULMONARY ERGOMETER | January 19, 1988 |
| K864890 | shiley | STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP | February 19, 1987 |
| K862510 | shiley | STOCKERT-SHILEY CAPS 4 CHANNEL TEMP. MONITOR 1 | July 17, 1986 |
| K862549 | american bentley | ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE | July 15, 1986 |
| K860298 | cardio metrics | STABLELINE | April 2, 1986 |
| K860672 | american bentley | ADJUSTABLE OXYGENATOR HOLDER MODEL NO. BCM-HL | March 3, 1986 |
| K854113 | american bentley | CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH | January 8, 1986 |
| K852455 | gambro | GAMBRO DIGITAL TELETHERMOMETER TTH 10-200 | September 16, 1985 |
| K851077 | pat o. daily | CARDIAC COOLING JACKET | July 11, 1985 |
| K851289 | cobe laboratories | COBE GAS FILTER | June 19, 1985 |