510(k) K960479 ยท LDF Electrode, Pacemaker, Temporary
ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, Oct 17, 1996 |
| Received | Feb 2, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960479
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU Open, Classified |
LDF | None listed |
| Jun 24, 2009 | Arrow International Inc Arrow Balloon and stylet temporary pacing catheter Terminated |
LDF | None listed |
| Sep 16, 2008 | Arrow International Inc Arrow Balloon Temporary Pacing Catheter Kits, Part number AI-07155-KS, Lot number RF8015919, 5 Fr. (110 cm) Pacing Catheter, 6 Fr. Introducer Sheath, .035 inch diameter spring-wire guide, Single use. Terminated |
LDF | None listed |
| Sep 16, 2008 | Arrow International Inc Arrow Balloon Temporary Pacing Catheter Kits, Part number AI-07155-IK, Lot number RF8015920, For Export Only, 5 Fr. (110 cm) Pacing Catheter, 6 Fr. Introducer Sheath, .035 inch diameter spring-wire g Terminated |
LDF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.