510(k) K022880 ยท DXC Clamp, Vascular
GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500
| Applicant | Guidant Corp., Lafayette CA, US |
| Decision | Substantially Equivalent, Sep 13, 2002 |
| Received | Aug 30, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022880
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2011 | Maquet Cardiovascular, LLC Maquet Heartstring II Proximal Seal System (HS-1045) manufactured by Maquet Cardiovascular, Wayne, NJ
Intended use: medical device for use by cardiac surgeons during CABG procedures to maintain hemos Terminated |
DXC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.