K062569 is an FDA 510(k) clearance for the SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING. This device is classified as a Clamp, Vascular (Class II - Special Controls, product code DXC).
Submitted by Datascope Corp. (Manwah, US). The FDA issued a Cleared decision on February 14, 2007, 167 days after receiving the submission on August 31, 2006.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K062569 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2006 |
| Decision Date | February 14, 2007 |
| Days to Decision | 167 days |
| Submission Type | Abbreviated |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXC - Clamp, Vascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |