510(k) K962342 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH
| Applicant | Meadox Medicals, Div. Boston Scientific Corp., Oakland NJ, US |
| Decision | Substantially Equivalent, Sep 10, 1996 |
| Received | Jun 18, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962342
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 7, 2011 | Maquet Cardiovascular, LLC Hemashield Finesse Ultra-Thin Knitted Cardiovascular Patch
Indicated for cardiac and vascular patch grafting. The fabric is recommended for use in patients requiring systemic heparinization prior to, Terminated |
DSY | None listed |
| Jul 22, 2010 | Maquet Cardiovascular, LLC Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch. Terminated |
DSZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.