510(k) K070529 ยท FRN Pump, Infusion
AFF (MARK I) VOLUMETRIC INFUSION PUMP
| Applicant | Definitive Medical Technologies, Ltd., Lod, IL |
| Decision | Substantially Equivalent, May 8, 2007 |
| Received | Feb 23, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070529
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2016 | WalkMed Infusion, LLC The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution. Terminated |
FRN | None listed |
| Jul 18, 2016 | WalkMed Infusion, LLC The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution. Terminated |
FRN | None listed |
| Nov 6, 2015 | WalkMed Infusion, LLC Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetric Infusion Pump). Used to pump fluids into a patient in a controlled manner. Terminated |
FRN | None listed |
| Mar 3, 2014 | WalkMed Infusion, LLC Triton FP Infusion Pump, Part Number 400000, packaged in boxes.
The Triton Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nu Terminated |
FRN | None listed |
| Nov 5, 2010 | Walkmed Infusion LLC WalkMed Triton Pole Mount Infusion Pump, Catalog 300000.
Indicated for delivering infusions of medications, as well as providing total parenteral nutrition, and patient controlled analgesia. Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.