K123452 is an FDA 510(k) clearance for the TRACKER-17 MICROCATHER, 150 CM LONG AND 15.0 CM FLEXIBLE DISTAL SHAFT, TRACKER-17 MICROCATHETER, 150 CM LONG AND 7.5 CM. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Stryker (Fremont, US). The FDA issued a Cleared decision on January 3, 2013, 56 days after receiving the submission on November 8, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K123452 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2012 |
| Decision Date | January 03, 2013 |
| Days to Decision | 56 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 |