The following data is part of a premarket notification filed by G V Medical, Inc, with the FDA for Gv Medical, Inc. Lastac Balloon Dilatation Cathete.
| Device ID | K851080 |
| 510k Number | K851080 |
| Device Name: | GV MEDICAL, INC. LASTAC BALLOON DILATATION CATHETE |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | G V MEDICAL, INC, 3750 ANNAPOLIS LN. Minneapolis, MN 55441 |
| Contact | Russel W Felkey |
| Correspondent | Russel W Felkey G V MEDICAL, INC, 3750 ANNAPOLIS LN. Minneapolis, MN 55441 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-18 |
| Decision Date | 1985-06-20 |