The following data is part of a premarket notification filed by Medco Products, Co., Inc. with the FDA for Rotary Vascular Knife.
| Device ID | K822829 |
| 510k Number | K822829 |
| Device Name: | ROTARY VASCULAR KNIFE |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | MEDCO PRODUCTS, CO., INC. 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 | 1982-09-21 |
| Decision Date | 1982-11-17 |