PRESSURE RELIEF VALVE
FDA 510(k) clearance K941492 · decided 1994-10-26
Clearance details
- K-number
- K941492
- Device name
- PRESSURE RELIEF VALVE
- Applicant
- Circulatory Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-03-28
- Decision date
- 1994-10-26
- Days to decision
- 212 days
- Clearance type
- Traditional
- Product code
- MNJ
- Device class
- 2
- Regulation number
- 870.4400
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Oyster Bay, NY, 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 |
|---|---|---|
| IBC VENT VALVE, MODEL 1400 (K992964) | International Biophysics Corp. | 1999-11-19 |
Recalls involving this device
No recalls on record reference this clearance.