K955349 is an FDA 510(k) clearance for the HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC. This device is classified as a Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (Class II - Special Controls, product code DXZ).
Submitted by Meadox Medicals, Div. Boston Scientific Corp. (Oakland, US). The FDA issued a Cleared decision on February 14, 1996, 85 days after receiving the submission on November 21, 1995.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3470.
| 510(k) Number | K955349 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 1995 |
| Decision Date | February 14, 1996 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXZ — Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3470 |