510(k) K040298 ยท DXT Injector And Syringe, Angiographic
ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS
| Applicant | Acist Medical Systems, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Mar 15, 2004 |
| Received | Feb 9, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040298
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 18, 2013 | Acist Medical Systems ACIST Medical Systems Inc.
The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures. Terminated |
DXT | None listed |
| Aug 30, 2009 | Acist Medical Systems ACIST Automated Manifold Kit , REF Model BT2000, SKU # 014613, Sterile R, Made in Mexico, Manufacturer; ACIST LMedical Systems Inc, 7605 Fuller Road, Eden Prairie, MN .55344.
The automated manifold ki Terminated |
DXT | None listed |
| Sep 23, 2008 | Acist Medical Systems ACIST" BRACCO, AT P54 AngioTouch Kit , SKU # 014644, Sterile EO Manufacturer; ACTB Medical Systems, Inc. 7905 Fuller Road, Eden Prairie, MN 55344, Made in Mexico.
Catalogue No: 800608-013
Intended t Terminated |
DXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.