510(k) K081940 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
AVALON ELITE VASCULAR ACCESS KIT
| Applicant | Avalon Laboratories, LLC, Rancho Dominguez CA, US |
| Decision | Substantially Equivalent, Nov 18, 2008 |
| Received | Jul 8, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081940
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2020 | Maquet Cardiovascular Us Sales, Llc Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039 Terminated |
DRE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.