510(k) K810859 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
SINGLE USE SELDINGER/COURNAND PERC. NDL
| Applicant | Procedure Products, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 11, 1981 |
| Received | Mar 30, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K810859
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2015 | Procedure Products, Inc. U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387.
All needles were sold in bulk, non-sterile, and intended for further processing. Needles are packaged in zipper-bags, 300 pieces per bag, wi Terminated |
DRE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.