K193474 is an FDA 510(k) clearance for the Selectra 3D Outer Guiding Catheters. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on October 16, 2020, 305 days after receiving the submission on December 16, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K193474 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2019 |
| Decision Date | October 16, 2020 |
| Days to Decision | 305 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |