510(k) K071998 ยท FMI Needle, Hypodermic, Single Lumen
ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, Sep 26, 2007 |
| Received | Jul 23, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071998
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 11, 2018 | Arrow International Inc Echogenic Introducer Needle; Product Code: AN-04318 Terminated |
FMI | None listed |
| Apr 11, 2018 | Arrow International Inc Echogenic Needle; Product codes: PN-00215-E and PN-00217-E Terminated |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.