The following data is part of a premarket notification filed by Applied Vascular Engineering, Inc. with the FDA for Ave Alliance Dilatation Catheter.
| Device ID | K931384 |
| 510k Number | K931384 |
| Device Name: | AVE ALLIANCE DILATATION CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | APPLIED VASCULAR ENGINEERING, INC. 5345 SKYLANE BLVD. Santa Rosa, CA 95403 |
| Contact | John A Schiek |
| Correspondent | John A Schiek APPLIED VASCULAR ENGINEERING, INC. 5345 SKYLANE BLVD. Santa Rosa, CA 95403 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-18 |
| Decision Date | 1993-09-17 |