K162181 is an FDA 510(k) clearance for the Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set. This device is classified as a Dilator, Vessel, For Percutaneous Catheterization (Class II - Special Controls, product code DRE).
Submitted by Cardiacassist, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on January 6, 2017, 155 days after receiving the submission on August 4, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1310.
| 510(k) Number | K162181 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2016 |
| Decision Date | January 06, 2017 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRE — Dilator, Vessel, For Percutaneous Catheterization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1310 |