510(k) K130382 ยท DXC Clamp, Vascular
HEARTSTRING III PROXIMAL SEAL SYSTEM
| Applicant | Boston Scientific Corporation, Wayne NJ, US |
| Decision | Substantially Equivalent, Jun 5, 2013 |
| Received | Feb 14, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130382
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2025 | Maquet Cardiovascular, LLC Heartstring III Proximal Seal System. Intravascular anastomosis occluder. Open, Classified |
DXC | None listed |
| Sep 18, 2025 | Maquet Cardiovascular, LLC Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder. Open, Classified |
DXC | None listed |
| Sep 18, 2025 | Maquet Cardiovascular, LLC Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder. Open, Classified |
DXC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.