K172557 is an FDA 510(k) clearance for the Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach. This device is classified as a Filter, Intravascular, Cardiovascular (Class II - Special Controls, product code DTK).
Submitted by William Cook Europe Aps (Bjaeverskov, DK). The FDA issued a Cleared decision on November 20, 2017, 88 days after receiving the submission on August 24, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3375.
| 510(k) Number | K172557 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 2017 |
| Decision Date | November 20, 2017 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTK - Filter, Intravascular, Cardiovascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3375 |