510(k) K963368 · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLE

Applicant	Glycar, Inc., Dallas TX, US
Decision	Substantially Equivalent, Oct 31, 1997
Received	Aug 27, 1996
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K963368

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.