The following data is part of a premarket notification filed by Sil-med Corp. with the FDA for Vascular Tie (vas-tie).
| Device ID | K810080 |
| 510k Number | K810080 |
| Device Name: | VASCULAR TIE (VAS-TIE) |
| Classification | Instrument, Surgical, Disposable |
| Applicant | SIL-MED CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KDC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-13 |
| Decision Date | 1981-04-02 |