510(k) K111417 ยท DYB Introducer, Catheter
THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
| Applicant | Access Scientific, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jul 15, 2011 |
| Received | May 20, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111417
| 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.