Submission Details
| 510(k) Number | K162467 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 02, 2016 |
| Decision Date | February 01, 2017 |
| Days to Decision | 152 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Twin-Pass Torque
Feb 2017
Decision
152d
Days
Class 2
Risk
About This 510(k) Submission
K162467 is an FDA 510(k) clearance for the Twin-Pass Torque, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Vascular Solutions, Inc. (Maple Grove, US). The FDA issued a Cleared decision on February 1, 2017, 152 days after receiving the submission on September 2, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.
Device Classification
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
Manufacturer
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