The following data is part of a premarket notification filed by American V. Mueller with the FDA for Leather Valvulotome.
| Device ID | K821569 |
| 510k Number | K821569 |
| Device Name: | LEATHER VALVULOTOME |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | AMERICAN V. MUELLER 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Se - Postmarket Surveillance Required (SESP) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-27 |
| Decision Date | 1982-05-27 |