510(k) K011336 ยท FPA Set, Administration, Intravascular
PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK
| Applicant | Churchill Medical Systems, Inc., Dover NH, US |
| Decision | Substantially Equivalent, Jun 12, 2001 |
| Received | May 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011336
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 16, 2011 | Churchill Medical Systems, Inc. WalkMed Infusion Triton 90" 20 drop IV Administration Set with 2 Needlefree Y-sites and Back Check Valve; Item # T090-000W
Intended use: Intravascular Administration Set Terminated |
FPA | None listed |
| Feb 16, 2011 | Churchill Medical Systems, Inc. WalkMed Infusion Triton 90" 20 drop IV Administration Set with Needlefree Y-site
Item # T090-000V
Intended use: Intravascular Administration Set Terminated |
FPA | None listed |
| Feb 16, 2011 | Churchill Medical Systems, Inc. WalkMed Infusion Triton 90" 20 drop IV Administration Set with Needlefree Y-site and 0.22
Intended use: Intravascular Administration Set Terminated |
FPA | None listed |
| Feb 16, 2011 | Churchill Medical Systems, Inc. WalkMed Infusion Triton 90" 20 drop IV Administration Set;
Manufactured for Walked Infusion 96 Inverness Drive East, Suite 14 Englewood, CO 80112
Item # T090-000
Intended use: Intravascular Administ Terminated |
FPA | None listed |
| Feb 16, 2011 | Churchill Medical Systems, Inc. WalkMed Infusion 100" 20 drop IV Administration Set with 1 Needlefree Y-site and Free Flow Protection Clip
Manufactured for WalkMed Infusion 96 Inverness Drive East Suite 1 Engelwood, CO 80112
Item # Terminated |
FPA | None listed |
| Feb 16, 2011 | Churchill Medical Systems, Inc. Walkmed Infusion Triton 100" 20 Drop IV Administration Set with Free Flow Protection Clip; Manufactured for: WalkMed Infusion 96 Inverness Drive East, Suite 1 Englewood, CO 80112
Item # T100-000F
Int Terminated |
FPA | None listed |
| Feb 16, 2011 | Churchill Medical Systems, Inc. Churchill Medical Systems Fluid Transfer Set; Sterile
Item # AMS-451
Intended use: Intravascular Administration Set Terminated |
FPA | None listed |
| Feb 16, 2011 | Churchill Medical Systems, Inc. FMI 105"Oral Surgery Administration Set;
Item AMS-468-1
Manufactured For: First Medical inc., 8515 Douglas Ave., Suite 23 Urbandale, IA 50322
Intended use: Intravascular Administration Set Terminated |
FPA | None listed |
| May 21, 2010 | Churchill Medical Systems, Inc. Churchill Medical Systems Bag Access Device w/Smartsite Needleless Injection Site, Sterile, Non pyrogenic, Latex Free Product Code: KSA-140. Churchill Medical Systems, Inc. Dover, NH 03820.
Intrava Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.