510(k) K900263 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Unknown, Jul 24, 1990 |
| Received | Jan 18, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900263
| 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 |
| May 17, 2019 | Arrow International Inc Pediatric Two-Lumen Central Venous Catheterization
Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502
Product Usage; Provide short-term (< 30 days) central venous access for treatment of d Terminated |
FOZ | None listed |
| Jul 3, 2018 | Arrow International Inc Pediatric Two-Lumen Central Venous
Catheterization Kit with Blue FlexTip
ARROWg+ard Blue Catheter, Cat. No. AK-22502
Product Usage:
The multiple-lumen catheter permits venous access to the central c Terminated |
FOZ | None listed |
| Apr 11, 2018 | Arrow International Inc Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter and Sharps Safety Features; Product Code: ASK-24306-VC Terminated |
FOZ | None listed |
| Apr 11, 2018 | Arrow International Inc ARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-24306-WHC1 and ASK-24306-WHC2 Terminated |
FOZ | None listed |
| Dec 22, 2017 | Arrow International Inc ARROWg+ard Blue CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-24306-1A; (3) ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit, PN: CDC-22123-1A; (4) Central Venous Catheterization Kit with Blu Terminated |
FOZ | None listed |
| Nov 27, 2017 | Arrow International Inc ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit
Product Usage:
The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring cent Terminated |
FOZ | None listed |
| May 9, 2017 | Arrow International Inc ARROWg+ard Blue CVC Kit
The ARROWg+ard Blue CVCs are intended to permit venous access to the central circulation Terminated |
FOZ | None listed |
| Jun 26, 2012 | Arrow International Inc Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter
Product Usage:
The multiple-lumen catheter permits venous access to central circulation. Terminated |
FOZ | None listed |
| Sep 25, 2010 | Arrow International Inc Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter Terminated |
FOZ | None listed |
| Jun 24, 2009 | Arrow International Inc Arrow ARROWg+ard CVCs (Central Venous Catheters) Terminated |
FOZ | None listed |
| Nov 1, 2003 | Arrow International Inc Arrow Howes multi-lumen central venous catheterization kit 7 Fr x 20 cm Terminated |
KZH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.