510(k) K941492
- Device
- PRESSURE RELIEF VALVE
- Applicant
- CIRCULATORY TECHNOLOGY, INC.
- 510(k) number
- K941492
- Product code
- MNJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-10-26
- Date received
- 1994-03-28
- Regulation
- 870.4400
- Classification name
- Valve, Pressure Relief, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- YEHUDA TAMARI
- Address
- 21 Singworth St. Oyster Bay NY US 11771 11771
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MNJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K992964 | IBC VENT VALVE, MODEL 1400 | International Biophysics Corp. | 1999-11-19 |
Legacy Summary#
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FDA Review#
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