The following data is part of a premarket notification filed by Medtronic Cardiac Surgery, Medtronic, Inc. with the FDA for Medtronic Overpressure/vacuum Relief Valve.
| Device ID | K953564 |
| 510k Number | K953564 |
| Device Name: | MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC. 4633 EAST LA PALMA AVE. Anaheim, CA 92807 |
| Contact | Wayne R Hohman |
| Correspondent | Wayne R Hohman MEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC. 4633 EAST LA PALMA AVE. Anaheim, CA 92807 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-31 |
| Decision Date | 1996-02-02 |