510(k) K040415 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT
| Applicant | Synovis Surgical Innovations, St. Paul MN, US |
| Decision | Substantially Equivalent, Apr 14, 2004 |
| Received | Feb 18, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040415
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2010 | Synovis Surgical Inovation Div. of PSD Gel that's provided with Peri-Strips Dry Staple Line Reinforcement with Apex Processing (PSD) and Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V) products. Sterile, Terminated |
DXZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.