510(k) K010390 ยท DXT Injector And Syringe, Angiographic
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS
| Applicant | Acist Medical Systems, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Mar 9, 2001 |
| Received | Feb 9, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010390
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 8, 2009 | Acist Medical Systems ACIST CVi Angiographic Injection System with Interface Cable for Toshiba Infinix-i cardiovascular X-ray system, Part Number 700318-002. The ACIST injection system is an angiographic injection system Terminated |
DXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.