K173762 is an FDA 510(k) clearance for the AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on July 18, 2018, 219 days after receiving the submission on December 11, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K173762 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2017 |
| Decision Date | July 18, 2018 |
| Days to Decision | 219 days |
| Submission Type | Special |
| 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 |