510(k) K052744 ยท DXT Injector And Syringe, Angiographic
C2000 AUTOMATED MANIFOLD KIT
| Applicant | Acist Medical Systems, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Dec 16, 2005 |
| Received | Sep 30, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052744
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.