The following data is part of a premarket notification filed by Key Surgical, Inc. with the FDA for Key Vascular Loops.
| Device ID | K896676 |
| 510k Number | K896676 |
| Device Name: | KEY VASCULAR LOOPS |
| Classification | Instrument, Surgical, Disposable |
| Applicant | KEY SURGICAL, INC. 7101 YORK AVENUE SOUTH Minneapolis, MN 55435 -4450 |
| Contact | Kay Nordbye |
| Correspondent | Kay Nordbye KEY SURGICAL, INC. 7101 YORK AVENUE SOUTH Minneapolis, MN 55435 -4450 |
| Product Code | KDC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-27 |
| Decision Date | 1990-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10849771030833 | K896676 | 000 |
| 10849771050541 | K896676 | 000 |
| 50849771050778 | K896676 | 000 |