510(k) K013871 ยท FPA Set, Administration, Intravascular
LIFEGUARD SAFETY INFUSION SET
| Applicant | Horizon Medical Products, Inc., Manchester GA, US |
| Decision | Substantially Equivalent, Mar 29, 2002 |
| Received | Nov 21, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013871
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2017 | Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. 20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034. Terminated |
FPA | None listed |
| Mar 6, 2013 | Churchill Medical Systems, Inc. Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010
Huber type needle set used for the infusion of medical fluids into implantable ports. Terminated |
FPA | None listed |
| Feb 16, 2011 | Churchill Medical Systems, Inc. Churchill Medical Systems LifeGuard Non-Coring Huber Needle, Lifeguard Non-Coring Safety Infusion Set 22GA, 3/4"; Item # CLG-2234
The Lifeguard Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.