K062609 is an FDA 510(k) clearance for the MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on October 6, 2006, 31 days after receiving the submission on September 5, 2006.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K062609 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 2006 |
| Decision Date | October 06, 2006 |
| Days to Decision | 31 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |