510(k) K143102 ยท NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions
| Applicant | Arrow International, Inc. (Subsidiary of Teleflex, Inc.), Reading PA, US |
| Decision | Unknown, Jul 24, 2015 |
| Received | Oct 29, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143102
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC;
AHDC KIT: 3-L 12 FR X 20 CM/AK-15123-PCDC;
AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XP1A;
AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XP1A;
AHDC KIT: Open, Classified |
NIE | None listed |
| Dec 22, 2017 | Arrow International Inc Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Part Number: CDC-12123-P1A Terminated |
NIE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.