510(k) K924607 ยท DYB Introducer, Catheter
ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SET
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, Apr 22, 1993 |
| Received | Sep 11, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K924607
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 12, 2016 | Arrow International Inc Super Arrow-Flex Percutaneous Sheath Introducer Sets
REF CL-07035 or CL-07635 or CL-07735 or CL-07835
Super Arrow-Flex
Percutaneous Sheath Introducer Set
with Integral Hemostasis Valve/Side Port
and Terminated |
DYB | None listed |
| Jun 24, 2009 | Arrow International Inc Arrow Super Arrow-Flex Percutaneous Sheath Introducers Terminated |
DYB | None listed |
| Nov 1, 2003 | Arrow International Inc 10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set Terminated |
KZH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.