510(k) K200955 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch
| Applicant | Vascutek, Ltd., Inchinnan, GB |
| Decision | Substantially Equivalent, Jul 8, 2020 |
| Received | Apr 9, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200955
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.