K122405 is an FDA 510(k) clearance for the AIR-BAND RADIAL COMPRESSION DEVICE. This device is classified as a Clamp, Vascular (Class II - Special Controls, product code DXC).
Submitted by Datascope Corp., Cardiac Assist Division (Fairfield, US). The FDA issued a Cleared decision on November 9, 2012, 94 days after receiving the submission on August 7, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K122405 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 2012 |
| Decision Date | November 09, 2012 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXC - Clamp, Vascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |