K051655 is an FDA 510(k) clearance for the ANGIODYNAMICS, INC., MICRO ACCESS KITS. This device is classified as a Cannula, Catheter (Class II - Special Controls, product code DQR).
Submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on September 12, 2005, 83 days after receiving the submission on June 21, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1300.
| 510(k) Number | K051655 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2005 |
| Decision Date | September 12, 2005 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DQR — Cannula, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1300 |