510(k) K020544 ยท FPA Set, Administration, Intravascular
WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA
| Applicant | Churchill Medical Systems, Inc., Dover NH, US |
| Decision | Substantially Equivalent, Mar 12, 2002 |
| Received | Feb 15, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K020544
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 16, 2011 | Churchill Medical Systems, Inc. Winged Infusion Set with 90 degree Huber Needle and Y Injection Site
Distributed By: FloridaInfustion Services, Inc., Palm Harbor, FL 34683
Item # FIY-2210
Intended use: Intravascular Administratio Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.