The following data is part of a premarket notification filed by Vascor, Inc. with the FDA for Disposable Holder For Hancock Mitral.
| Device ID | K811235 |
| 510k Number | K811235 |
| Device Name: | DISPOSABLE HOLDER FOR HANCOCK MITRAL |
| Classification | Holder, Heart-valve, Prosthesis |
| Applicant | VASCOR, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DTJ |
| CFR Regulation Number | 870.3935 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-04 |
| Decision Date | 1981-05-13 |