510(k) K944320 ยท FPA Set, Administration, Intravascular
VENTED/NON-VENTED GEMINI ADMINISTRATION SET
| Applicant | Imed Corp., San Diego CA, US |
| Decision | Substantially Equivalent, Feb 14, 1995 |
| Received | Aug 29, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944320
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2021 | CAREFUSION BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: 10015012; BD Alaris Pump Infusion Buerette Set Ball Valve Smallbore Tubing Smart Open, Classified |
FPA | None listed |
| Feb 15, 2016 | CareFusion 303, Inc. Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007 Terminated |
FPA | None listed |
| Dec 17, 2015 | CareFusion 303, Inc. Alaris Pump SmartSite Infusion Set, Model No. 2420-0500.
Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. Terminated |
FPA | None listed |
| Jul 9, 2014 | CareFusion 303, Inc. SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A
14035457
14035485
14046894
14035458 Terminated |
FPA | None listed |
| Dec 4, 2013 | CareFusion 303, Inc. SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T
The SmartSite Low Sorbing Infusion Sets with Texium Male Luer are used to administer fluid and medications throug Terminated |
FPA | None listed |
| Dec 3, 2013 | CareFusion 303, Inc. VersaSafe Extension Set, Model No. 21000M-007 Terminated |
FPA | None listed |
| Sep 26, 2013 | CareFusion 303, Inc. SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set. Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.