IBC VENT VALVE, MODEL 1400
FDA 510(k) clearance K992964 · decided 1999-11-19
Clearance details
- K-number
- K992964
- Device name
- IBC VENT VALVE, MODEL 1400
- Applicant
- International Biophysics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-09-02
- Decision date
- 1999-11-19
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- MNJ
- Device class
- 2
- Regulation number
- 870.4400
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Austin, TX, 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 |
|---|---|---|
| PRESSURE RELIEF VALVE (K941492) | Circulatory Technology, Inc. | 1994-10-26 |
Recalls involving this device
No recalls on record reference this clearance.