510(k) K984231 ยท DXT Injector And Syringe, Angiographic
ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B
| Applicant | Invasatec, Eden Prairie MN, US |
| Decision | Substantially Equivalent, May 31, 2000 |
| Received | Nov 25, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984231
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2016 | Acist Medical Systems ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only, Made in Mexico.
The manifold body is identical in the BT2000 Terminated |
DXT | None listed |
| Dec 8, 2007 | Acist Medical Systems ACIST Multi-Use Syringe Kit, Model A2000; SKU # : 014612; labeled as STERILE; Manufactured: Acist Medical Systems, Inc., 7450 Flying Cloud Drive, Suite 150, Eden Prairie, MN 55344, USA. Catalogue No: 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.