510(k) K993691 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, Mar 8, 2000 |
| Received | Nov 1, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993691
| 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 |
| Jan 6, 2021 | Arrow International Inc Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the
femoral, jugular, or subclavian veins.
Product Code: CDC-45703-1A Terminated |
FOZ | None listed |
| Jul 18, 2019 | Arrow International Inc Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins
Product Code: CDC-42703-1A - Product Usage: The ARROWg+ard Blue PL Terminated |
FOZ | None listed |
| Sep 21, 2018 | Arrow International Inc Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code CDC-45703-B1A - Product Usage: The multiple-lumen catheter permits venous access to Terminated |
FOZ | None listed |
| Aug 30, 2018 | Arrow International Inc Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requi Terminated |
FOZ | None listed |
| Apr 11, 2018 | Arrow International Inc Double-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42802-VC and ASK-47702-VC Terminated |
FOZ | None listed |
| Apr 11, 2018 | Arrow International Inc Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42802-DMC Terminated |
FOZ | None listed |
| Apr 11, 2018 | Arrow International Inc Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product code: ASK-45703-AEH Terminated |
FOZ | None listed |
| Apr 11, 2018 | Arrow International Inc Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions; Product Codes: ASK-45703-SCH; ASK-45703- Terminated |
FOZ | None listed |
| Apr 11, 2018 | Arrow International Inc ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter; Product Code: ASK-45703-VC Terminated |
FOZ | None listed |
| Mar 21, 2018 | Arrow International Inc ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG
Product Usage:
The ARROWg+ard Blue PLUS catheter permits venous access to central circulation by way of subclavian, jugular, and femoral ve Terminated |
FOZ | None listed |
| Feb 20, 2018 | Arrow International Inc ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code: AK-45703-ACDC; Exp. Dates Feb 2018 - Nov 2018 Terminated |
FOZ | None listed |
| Dec 22, 2017 | Arrow International Inc AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3) CDC-45703-1A, (4) CDC-45703-A1A, (5) PN: CDC-45703-B1A; AGB+ Quad-Lumen CVC Kit (6) PN: CDC-42854-1A, (7) PN: CD Terminated |
FOZ | None listed |
| May 9, 2017 | Arrow International Inc Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features.
The multiple-lumen catheter permits venous access to the central circ Terminated |
FOZ | None listed |
| Apr 24, 2014 | Arrow International Inc Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC. Terminated |
FOZ | None listed |
| Sep 25, 2010 | Arrow International Inc Two-Lumen Central Venous Catheterization kit with Blue FlexTip ARROW g+ard Blue PLUS Catheter, Sharps Safety Features, and Maximal Barrier Precautions Terminated |
FOZ | None listed |
| Mar 5, 2010 | Arrow International Inc Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. The product is shipped in cases contain Terminated |
FOZ | None listed |
| Mar 5, 2010 | Arrow International Inc Two-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. The product is shipped in cases containin Terminated |
FOZ | None listed |
| Mar 5, 2010 | Arrow International Inc Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. (contains Q-Syte) Terminated |
FOZ | None listed |
| Mar 5, 2010 | Arrow International Inc Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. (contains Q-Syte) Terminated |
FOZ | None listed |
| Jun 24, 2009 | Arrow International Inc Arrow ARROWg+ard Blue Plus Multi-Lumen CVCs (Central Venous Catheters) Terminated |
FOZ | None listed |
| Oct 28, 2004 | Arrow International Inc Arrowg+ard Blue Two Lumen CVC Super Kit, Catalog number AK-22802-SK. The kit actually contains Arrowg+ard Blue Plus Two Lumen CVC Super Kit. Catalog number AK-42802-SK, 8 Fr x 16 cm Two Lumen Arrowg+a Terminated |
FOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.