510(k) K071574 ยท DYB Introducer, Catheter
STIFFER COAXIAL MICRO-INTRODUCER KIT
| Applicant | Enpath Medical, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Jul 5, 2007 |
| Received | Jun 8, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071574
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2016 | Greatbatch Medical Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR; 10904-002 Stiffer Coaxial Micro-Introducer 5FR.
The radiopaque Stiffer Coaxial Micro-Introd Terminated |
DYB | None listed |
| Oct 7, 2016 | Argon Medical Devices, Inc MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F.
A sheath used to facilitate placing a catheter through the skin into a vein or artery. Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.