510(k) K252653 ยท DXT Injector And Syringe, Angiographic
ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable
| Applicant | Acist Medical Systems, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, May 13, 2026 |
| Received | Aug 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252653
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.