K812254 is an FDA 510(k) clearance for the DACRON PLEDGET SUTURE BUTTRESS. This device is classified as a Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (Class II - Special Controls, product code DXZ).
Submitted by Ethicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1981, 19 days after receiving the submission on August 12, 1981.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3470.
| 510(k) Number | K812254 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 1981 |
| Decision Date | August 31, 1981 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DXZ — Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3470 |