510(k) K100615 ยท DYB Introducer, Catheter
ARSTASIS ACCESS SYSTEM
| Applicant | Arstasis, Inc., San Carlos CA, US |
| Decision | Substantially Equivalent, Mar 30, 2010 |
| Received | Mar 4, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100615
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2011 | Arstasis, Inc Arstasls One Access System; Models: AAD100, AAD101, Part Numbers: FG-02279, FG-03010; The system consists of the following components: (1) Device Sheath/Anchor, (2) Shaft
and (3) Handle with control Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.