K192422 is an FDA 510(k) clearance for the Steerable Introducer 12F. This device is classified as a Catheter, Steerable (Class II - Special Controls, product code DRA).
Submitted by Freudenberg Medical, LLC (Jeffersonville, US). The FDA issued a Cleared decision on October 4, 2019, 30 days after receiving the submission on September 4, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1280.
| 510(k) Number | K192422 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2019 |
| Decision Date | October 04, 2019 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRA — Catheter, Steerable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1280 |