Submission Details
| 510(k) Number | K162563 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
YOGA Microcatheter
Jan 2017
Decision
113d
Days
Class 2
Risk
About This 510(k) Submission
K162563 is an FDA 510(k) clearance for the YOGA Microcatheter, 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 review panel. Regulated under 21 CFR 870.1250.
Device Classification
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
Manufacturer
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