K151409 is an FDA 510(k) clearance for the Selectra Catheters and Selectra Accessory Kit. 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 August 7, 2015, 73 days after receiving the submission on May 26, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K151409 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | May 26, 2015 |
| Decision Date | August 07, 2015 |
| Days to Decision | 73 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |