VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR
FDA 510(k) clearance K770681 · decided 1977-04-26
Clearance details
- K-number
- K770681
- Device name
- VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR
- Applicant
- Scimed Life Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-04-11
- Decision date
- 1977-04-26
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- KRI
- Device class
- 1
- Regulation number
- 870.4200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| AMMEX TUBING ORGANIZER (K934782) | Ammex Cardiopulmonary Corp. | 1993-11-18 |
| CARDIO2 CYCLE (K926233) | Ergometrix, Inc. | 1993-06-04 |
| TUBE GRIP (K922404) | Georgia Medical Products, Inc. | 1992-11-23 |
| NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS (K892856) | Acacia Laboratories, Inc. | 1989-11-08 |
| CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 (K884893) | American Omni Medical, Inc. | 1989-01-30 |
| CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 (K884640) | American Omni Medical, Inc. | 1989-01-24 |
| HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR (K874605) | Mallinckrodt Critical Care | 1988-02-02 |
| CPE 2000 CARDIO PULMONARY ERGOMETER (K874925) | Medical Graphics Corp. | 1988-01-19 |
| STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP (K864890) | Shiley, Inc. | 1987-02-19 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| APEX MONORAIL & APEX OTW PTCA DILATATION CATHETER/MAVERICK2 MONORAIL PTCA CATHETER/MAVERICK OTW PTCA CATHETER/MAVERICK (P860019/S264) | Scimed Life Systems, Inc. | 2011-03-31 |
| APEX PTCA & NC QUANTUM APEX PTCA CATHETERS (P860019/S263) | Scimed Life Systems, Inc. | 2010-09-08 |
| MAVERICK2 MONORAIL PTCA DILATATION CATHETER (P860019/S261) | Scimed Life Systems, Inc. | 2010-09-08 |
| PTCA CATHETERS (MAVERICK2/MAVERICK/MAVERICK XL/QUANTUM/MAVERICK/APEX) (P860019/S260) | Scimed Life Systems, Inc. | 2010-09-01 |
| PTCA CATHETERS (P860019/S259) | Scimed Life Systems, Inc. | 2010-08-13 |
| BSC APEX MONORAIL & OTW PTCA DILATATION CATHETERS (P860019/S258) | Scimed Life Systems, Inc. | 2010-07-28 |
| MAVERICK2 MONORAIL & MAVERICK OTW PTCA DILATATION CATHETERS (P860019/S256) | Scimed Life Systems, Inc. | 2010-06-23 |
| APEX PTCA DILATATION CATHETER (P860019/S255) | Scimed Life Systems, Inc. | 2010-05-27 |