510(k) K040527 ยท FPA Set, Administration, Intravascular
LOW PROFILE LUTHER SAFETY HUBER
| Applicant | Luther Needlesafe Products, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Mar 26, 2004 |
| Received | Mar 1, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040527
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2017 | Bard Access Systems SafeStep Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Packaged as single units in thermoformed trays. There are 25 SafeStep trays per case and 100 per carton.
Product Usage:
Inten Terminated |
FPA | None listed |
| Mar 13, 2015 | Bard Access Systems BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep Port Access Kit 22G x 0.75in , SafeStep Port Access Kit 22G x 0.75in with Y-Site, SafeStep Port Access Kit 22G Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.