Submission Details
| 510(k) Number | K173762 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters
Jul 2018
Decision
219d
Days
Class 2
Risk
About This 510(k) Submission
K173762 is an FDA 510(k) clearance for the AngioDynamics, Inc. Soft-Vu and Mariner Angiographic 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 July 18, 2018, 219 days after receiving the submission on December 11, 2017. 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 |
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