The following data is part of a premarket notification filed by Circulatory Technology, Inc. with the FDA for Pressure Relief Valve.
| Device ID | K941492 |
| 510k Number | K941492 |
| Device Name: | PRESSURE RELIEF VALVE |
| Classification | Valve, Pressure Relief, Cardiopulmonary Bypass |
| Applicant | CIRCULATORY TECHNOLOGY, INC. 21 SINGWORTH ST. Oyster Bay, NY 11771 |
| Contact | Yehuda Tamari |
| Correspondent | Yehuda Tamari CIRCULATORY TECHNOLOGY, INC. 21 SINGWORTH ST. Oyster Bay, NY 11771 |
| Product Code | MNJ |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-28 |
| Decision Date | 1994-10-26 |