Submission Details
| 510(k) Number | K161596 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters
Apr 2017
Decision
323d
Days
Class 2
Risk
About This 510(k) Submission
K161596 is an FDA 510(k) clearance for the Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters, 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 review panel. Regulated under 21 CFR 870.1200.
Device Classification
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1200 |
Manufacturer
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