CENTRI-SAFE(TM) VALVE
FDA 510(k) clearance K921500 · decided 1992-09-15
Clearance details
- K-number
- K921500
- Device name
- CENTRI-SAFE(TM) VALVE
- Applicant
- Cardio Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-03-31
- Decision date
- 1992-09-15
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- MJJ
- Device class
- 2
- Regulation number
- 870.4400
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Conshohocken, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MiniGuard Arterial Safety Valve (K182442) | Quest Medical, Inc. | 2018-11-06 |
| One Way Soft Valve (K142500) | Terumo Cardiovascular Systems Corporation | 2015-01-29 |
| 3T L. V. CONTROL VALVE (K001245) | 3t Medical Systems, LLC | 2001-08-15 |
| IBC FLOGUARD, MODEL 6050 (K992785) | International Biophysics Corp. | 2000-01-14 |
| COBE VACUUM RELIEF CHECK VALVE (K982406) | Cobe Cardiovascular, Inc. | 1998-10-07 |
| SUCTION SAFETY DEVICE (K960937) | R D Intl. | 1996-06-05 |
| FLOW CONROL VALVE (K922781) | American Omni Medical, Inc. | 1993-03-08 |
| FLOW CONTROL VALVE, CAT. NO. ACV-38 (K922356) | American Omni Medical, Inc. | 1993-02-12 |
Recalls involving this device
No recalls on record reference this clearance.