510(k) K991103 ยท DXT Injector And Syringe, Angiographic
MODIFICATION TO ACIST CL 100H
| Applicant | Acist Medical Systems, Eden Prairie MN, US |
| Decision | Substantially Equivalent, May 31, 2000 |
| Received | Apr 1, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991103
| 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 |
| Jul 20, 2004 | Acist Medical Systems AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management System. Terminated |
DXT | None listed |
| Oct 24, 2003 | Acist Medical Systems ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Contrast Management Systems (CMS2000) and E2000 Voyager Units) Terminated |
DXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.