K984627 is an FDA 510(k) clearance for the AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Arterial Vascular Engineering, Inc. (Billerica, US). The FDA issued a Cleared decision on July 27, 1999, 209 days after receiving the submission on December 30, 1998.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K984627 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 1998 |
| Decision Date | July 27, 1999 |
| Days to Decision | 209 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |