510(k) K083472 ยท FPA Set, Administration, Intravascular
MEDEGEN PRESSURE RATED EXTENSION SETS
| Applicant | Medegen, Inc., Ontario CA, US |
| Decision | Substantially Equivalent, Dec 9, 2008 |
| Received | Nov 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083472
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2026 | BD SWITZERLAND SARL 60 In Non-DEHP Minibore Extension Set RES ME2010
UDI-DI code: 10885403236235
MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C
UDI-DI code: 10885403274619
9 IN Extension Set w/Max Y REF MPX5300- Open, Classified |
FPA | None listed |
| May 2, 2019 | Becton Dickinson & Company CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to the IV line and/or IV catheter during IV therapy
Cat. No. MP1000-C Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.