K151667 is an FDA 510(k) clearance for the AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm. 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 November 13, 2015, 147 days after receiving the submission on June 19, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K151667 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 2015 |
| Decision Date | November 13, 2015 |
| Days to Decision | 147 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 |