Submission Details
| 510(k) Number | K161336 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 13, 2016 |
| Decision Date | August 11, 2016 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
VSI StraitSet micro-introducer kit
Aug 2016
Decision
90d
Days
Class 2
Risk
About This 510(k) Submission
K161336 is an FDA 510(k) clearance for the VSI StraitSet micro-introducer kit, a Dilator, Vessel, For Percutaneous Catheterization (Class II — Special Controls, product code DRE), submitted by Vascular Solutions, Inc. (Maple Grove, US). The FDA issued a Cleared decision on August 11, 2016, 90 days after receiving the submission on May 13, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1310.
Device Classification
| Product Code | DRE — Dilator, Vessel, For Percutaneous Catheterization |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1310 |
Manufacturer
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