510(k) K884552 ยท CAZ Anesthesia Conduction Kit
CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, Mar 14, 1989 |
| Received | Oct 31, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884552
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
ACCESS TRAY/ASK-04001-SUH-S;
ACCESS TRAY/ASK-04001-VM1;
STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS;
STIMUCATH SFTY KIT: 19G CTH, 17Gx8CM NDL/AB-19608-KS;
STIMUCATH SFTY KIT: Open, Classified |
CAZ | None listed |
| Dec 20, 2019 | Arrow International Inc Arrow EPIDURAL NEEDLE COMPONENT
AN-05505 Terminated |
CAZ | None listed |
| Dec 20, 2019 | Arrow International Inc Arrow EPIDURAL NEEDLE KIT
SL-05500 Terminated |
CAZ | None listed |
| Apr 11, 2018 | Arrow International Inc Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide wires; Product Code: AI-07000 Terminated |
CAZ | None listed |
| Apr 11, 2018 | Arrow International Inc Epidural Needle; Product Codes: AN-05501 and AN-05505 Terminated |
CAZ | None listed |
| Apr 11, 2018 | Arrow International Inc 0.2 Micron Flat Epidural Filter; Product Code: EF-05500 Terminated |
CAZ | None listed |
| Feb 10, 2015 | Arrow International Inc ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural space and are used as a conduit for epidural catheter placement. Terminated |
CAZ | None listed |
| Feb 1, 2011 | Arrow International Inc Arrow WH-02220 - Epidural Catheterization Kit with FlexTip Plus(R) Catheter
Intended use: Permits acccess to epidural space, Epidural Anesthesia Kit Terminated |
CAZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.