510(k) K955349 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC
| Applicant | Meadox Medicals, Div. Boston Scientific Corp., Oakland NJ, US |
| Decision | Substantially Equivalent, Feb 14, 1996 |
| Received | Nov 21, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955349
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2018 | GETINGE US SALES LLC HEMASHIELD Knitted Double Velour Cardiovascular Fabric Terminated |
DXZ | None listed |
| Jul 22, 2010 | Maquet Cardiovascular, LLC Hemashield Double Velour Cardiovascular Fabrics. Terminated |
DXZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.