K162563 is an FDA 510(k) clearance for the YOGA Microcatheter. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on January 5, 2017, 113 days after receiving the submission on September 14, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K162563 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 2016 |
| Decision Date | January 05, 2017 |
| Days to Decision | 113 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 |