510(k) K131300 ยท DYB Introducer, Catheter
THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
| Applicant | Access Scientific, LLC, San Diego CA, US |
| Decision | Substantially Equivalent, Jun 7, 2013 |
| Received | May 7, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K131300
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2013 | Access Scientific Inc POWERWAND Safety Introducer with Extended Dwell Catheter;
Catalog no. 92006.
Used to gain access to the vascular system to sample blood and administer fluids intravenously. Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.