510(k) K993933 ยท MPB Catheter, Hemodialysis, Non-Implanted
14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, Sep 14, 2000 |
| Received | Nov 18, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993933
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F;
HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122;
HEMODIALYSIS KIT 2L: 14 FR X 15CM AGB/AK-22142-CDC;
HEMODIALYSIS KIT 2L: 14 FR X 2 Open, Classified |
MPB | None listed |
| Feb 20, 2018 | Arrow International Inc ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22142-F, AK-25142-CDC, AK-25142-F; Exp. Dates Feb 2018 - Nov 2018 Terminated |
MPB | None listed |
| Dec 22, 2017 | Arrow International Inc ARROWg+ard Blue Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A; (2) PN: CDC-25122-1A; (3) PN: CDC-25142-1A; (4) CDC-26142-1A Terminated |
MPB | None listed |
| May 9, 2017 | Arrow International Inc 1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions
The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid ad Terminated |
MPB | None listed |
| Jul 20, 2004 | Arrow International Inc Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue FlexTip Arrowg+ard Blue Curved Catheter for high Volume Ifusions Terminated |
MPB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.