510(k) K081905 ยท MEB Pump, Infusion, Elastomeric
ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP
| Applicant | Westmed, Inc., Highlands Ranch CO, US |
| Decision | Substantially Equivalent, Jul 15, 2008 |
| Received | Jul 3, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081905
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2014 | B. Braun Medical, Inc. B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device.
AccuFlo devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administratio Terminated |
MEB | None listed |
| Feb 3, 2014 | B. Braun Medical, Inc. B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML
Generally used for delivery of antibiotic and local anesthesia medications. Terminated |
MEB | None listed |
| Oct 30, 2012 | First Medical Source LLC Medpro Elastomeric Infusion Pump.
AccuFlux, Model # CT-0020-100H.
Product Usage:
The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or e Terminated |
MEB | None listed |
| Nov 23, 2011 | Wolf Medical Supply Inc. Wolf Medical Supply, Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 60 mL, FLOW RATE 2mL/Hr, Model # CT-0020-060 Item # RFC060020. Manufactured by Medpro International (Thailand) L Terminated |
MEB | None listed |
| Nov 23, 2011 | Wolf Medical Supply Inc. Wolf Medical Supply, Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 100 mL, FLOW RATE 2mL/Hr. Model # CT-0020-100 Item # RFC100020.
Manufactured by Medpro International (Tha Terminated |
MEB | None listed |
| Nov 23, 2011 | Wolf Medical Supply Inc. Wolf Medical Supply Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 270 mL, FLOW RATE 2mL/Hr.
Model # CT-0020-270 Item # RFC270020.
Manufactured by Medpro International (Thailand) L Terminated |
MEB | None listed |
| Oct 24, 2011 | Progressive Medical Inc Medpro AccuFlo Elastomeric Infusion Device, Model #CT-0020-270C, packaged 12/box. The box label shows the product is Manufactured By: Medpro International (Thailand) Ltd. for Medpro Corporation Pte. Terminated |
MEB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.