Submission Details
| 510(k) Number | K171653 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 05, 2017 |
| Decision Date | July 03, 2017 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up
Jul 2017
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K171653 is an FDA 510(k) clearance for the YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on July 3, 2017, 28 days after receiving the submission on June 5, 2017. 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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