510(k) K970864 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, Oct 17, 1997 |
| Received | Mar 10, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970864
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH;
CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F;
CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-15123-F;
3L CVC KIT: 7 FR X 16 CM/ASK-12703-PMAH;
3L PI CV Open, Classified |
LRS | None listed |
| Jun 27, 2022 | ARROW INTERNATIONAL Inc. Arrow Three-Lumen CVC Terminated |
FOZ | None listed |
| Aug 10, 2009 | Arrow International Inc 12 French 3 Lumen 16 cm Large-Bore Central Venous Catheters. Product numbers AK-12123-H, CS-12123-E, MA-12123, and MC-12123.
The large-bore multiple-lumen catheter permits venous access to the centr Terminated |
FOZ | None listed |
| Aug 10, 2009 | Arrow International Inc 12 French 3 Lumen 20 cm Large-Bore Central Venous Catheters. Product numbers AK-15123-H, AK-15123-J, CS-15123-E, and MC-15123.
The large-bore multiple-lumen catheter permits venous access to the cen Terminated |
FOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.