510(k) K073444 ยท FPA Set, Administration, Intravascular
TRITON MEIDCAL TMED IV-SET
| Applicant | Triton Medical, LLC, Austin TX, US |
| Decision | Substantially Equivalent, Aug 18, 2008 |
| Received | Dec 7, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073444
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 14, 2016 | WalkMed Infusion, LLC Spike Set, 12" Microbore SPM-12. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a patient through a needle or catheter inserted into Terminated |
FPA | None listed |
| Jun 14, 2016 | WalkMed Infusion, LLC T030-000 -30" 20 Drop IV Admin Secondary Set. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a patient through a needle or catheter Terminated |
FPA | None listed |
| Jun 14, 2016 | WalkMed Infusion, LLC T090-000 90" 20 Drop IV Admin Set. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a patient through a needle or catheter inserted in Terminated |
FPA | None listed |
| Jun 14, 2016 | WalkMed Infusion, LLC T090-000V 90" 20 Drop IV Admin Set w/ Needlefree Y-Site. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a patient through a needle o Terminated |
FPA | None listed |
| Jun 14, 2016 | WalkMed Infusion, LLC T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a patient Terminated |
FPA | None listed |
| Jun 14, 2016 | WalkMed Infusion, LLC T090-022V 90" 20 Drop IV Admin Set Needle free Y-Site & 0.22 Fltr. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a patient through Terminated |
FPA | None listed |
| Jun 14, 2016 | WalkMed Infusion, LLC T095-022, IV Set with 0.22 Micron Filter. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a patient through a needle or catheter inse Terminated |
FPA | None listed |
| Jun 14, 2016 | WalkMed Infusion, LLC T095-120 IV Set with 1.2 Micron Filter. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a patient through a needle or catheter insert Terminated |
FPA | None listed |
| Jun 14, 2016 | WalkMed Infusion, LLC T100-000F, 100" IV Set with Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a patient through a needle or catheter in Terminated |
FPA | None listed |
| Jun 14, 2016 | WalkMed Infusion, LLC T100-000VF, IV Set with Lower Y Site and Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a patient through a needle o Terminated |
FPA | None listed |
| Jun 14, 2016 | WalkMed Infusion, LLC T100-000WF, IV Set with Upper Y-Site, Lower Y-Site, Back Check Valve, and Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a containe Terminated |
FPA | None listed |
| Jun 14, 2016 | WalkMed Infusion, LLC T100-022F with 0.22 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a patient through a needle or catheter Terminated |
FPA | None listed |
| Jun 14, 2016 | WalkMed Infusion, LLC T100-120F with 1.2 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a patient through a needle or catheter Terminated |
FPA | None listed |
| Jun 14, 2016 | WalkMed Infusion, LLC T105-000WC IV Set w/2 Y-Sites, BC Vlv & Filter Cap. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a patient through a needle or cat Terminated |
FPA | None listed |
| Jun 14, 2016 | WalkMed Infusion, LLC T100-022WF, IV Set with 2 Y-Sites, 0.22 micron filter, Back Check Valve, & FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case.
Product Usage:
Used to administer fluids from a container to a Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.