510(k) K113198 ยท DXT Injector And Syringe, Angiographic
NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML
| Applicant | Navilyst Medical, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, Nov 28, 2011 |
| Received | Oct 31, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113198
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 7, 2026 | Medline Industries, LP NAMIC Angiographic Control Syringe, labeled as follows:
1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007;
2. SYRINGE,8ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70084007;
3. MTS,SYRINGE,8ML,TR/ Open, Classified |
DXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.