510(k) K895417 ยท LFJ Catheter, Subclavian
ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, Jan 3, 1990 |
| Received | Sep 1, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895417
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F Open, Classified |
LFJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.