K171268 is an FDA 510(k) clearance for the Reverse 021 Micro Catheter, Reverse 027 Micro Catheter. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (Irvine, US). The FDA issued a Cleared decision on May 31, 2017, 30 days after receiving the submission on May 1, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K171268 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2017 |
| Decision Date | May 31, 2017 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |