K161596 is an FDA 510(k) clearance for the Soft-Vu, Mariner, Accu-Vu and AngioOptic 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 April 28, 2017, 323 days after receiving the submission on June 9, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K161596 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 2016 |
| Decision Date | April 28, 2017 |
| Days to Decision | 323 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 |