The following data is part of a premarket notification filed by American V. Mueller with the FDA for Leather Valve Cutter.
| Device ID | K831455 |
| 510k Number | K831455 |
| Device Name: | LEATHER VALVE CUTTER |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | AMERICAN V. MUELLER 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-06 |
| Decision Date | 1983-07-07 |