510(k) K001599 ยท FPA Set, Administration, Intravascular
ACTI-FLEX IV ADMINISTRATION SET
| Applicant | R-Group Intl., Gainesville FL, US |
| Decision | Substantially Equivalent, Sep 18, 2000 |
| Received | May 24, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001599
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2014 | RGI Medical Manufacturing, Inc. Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set
Product Usage:
Catheter extension set for high pressure procedures. Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.