510(k) K112398 ยท DYB Introducer, Catheter
TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT
| Applicant | Galt Medical, Buford GA, US |
| Decision | Substantially Equivalent, Apr 12, 2012 |
| Received | Aug 19, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112398
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2014 | Galt Medical Corporation GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO
Product Usage:
Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral Terminated |
DYB | None listed |
| Sep 4, 2014 | Galt Medical Corporation GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO
Product Usage:
Used in percutaneous procedures to introduce catheters and other intravasc Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.