K203179 is an FDA 510(k) clearance for the Fortress Introducer Sheath System. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Contract Medical International, GmbH (Dresden, DE). The FDA issued a Cleared decision on November 20, 2020, 25 days after receiving the submission on October 26, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K203179 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 2020 |
| Decision Date | November 20, 2020 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYB - Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |