Submission Details
| 510(k) Number | K101647 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 11, 2010 |
| Decision Date | August 06, 2010 |
| Days to Decision | 56 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
K101647 - WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500
(FDA 510(k) Clearance)
Aug 2010
Decision
56d
Days
Class 2
Risk
K101647 is an FDA 510(k) clearance for the WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Avinger, Inc. (Redwood City, US). The FDA issued a Cleared decision on August 6, 2010, 56 days after receiving the submission on June 11, 2010. 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 |
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