The following data is part of a premarket notification filed by Acist Medical Systems, Inc. with the FDA for Acist 4 French Angiographic Catheter.
| Device ID | K012983 |
| 510k Number | K012983 |
| Device Name: | ACIST 4 FRENCH ANGIOGRAPHIC CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | ACIST MEDICAL SYSTEMS, INC. 7450 FLYING CLOUDS DR. SUITE 150 Eden Prairie, MN 55344 |
| Contact | Carl M Beaurline |
| Correspondent | Carl M Beaurline ACIST MEDICAL SYSTEMS, INC. 7450 FLYING CLOUDS DR. SUITE 150 Eden Prairie, MN 55344 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-05 |
| Decision Date | 2002-03-13 |
| Summary: | summary |