K052642 is an FDA 510(k) clearance for the SUTURING WASHER. This device is classified as a Marker, Cardiopulmonary Bypass (vein Marker) (Class II - Special Controls, product code MAB).
Submitted by First Call, Inc. (Derby, US). The FDA issued a Cleared decision on January 17, 2006, 113 days after receiving the submission on September 26, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3450.
| 510(k) Number | K052642 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2005 |
| Decision Date | January 17, 2006 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MAB — Marker, Cardiopulmonary Bypass (vein Marker) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3450 |