Atlas FDA

ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER

FDA 510(k) clearance K071538 · decided 2007-08-30

Clearance details

K-number
K071538
Device name
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER
Applicant
Arrow International, Inc.
Decision
Substantially Equivalent
Date received
2007-06-05
Decision date
2007-08-30
Days to decision
86 days
Clearance type
Traditional
Product code
FOZ
Device class
2
Regulation number
880.5200
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Reading, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X recall (Z-2376-2026)ARROW INTERNATIONAL, LLC2026-06-13
Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A recall (Z-2123-2026)Medline Industries, LP2026-05-07
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF recall (Z-1914-2026)ARROW INTERNATIONAL, LLC2026-04-22
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC- recall (Z-0002-2024)ARROW INTERNATIONAL Inc.2023-10-05
Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter recall (Z-0003-2024)ARROW INTERNATIONAL Inc.2023-10-05
Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11 recall (Z-0351-2023)ARROW INTERNATIONAL Inc.2022-12-10
Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS recall (Z-0352-2023)ARROW INTERNATIONAL Inc.2022-12-10
TELEFLEX LLC Arrow Central Venous Catheter Kit 16, 18 Gauge Multi Lumen Model Number:CDC-4 recall (Z-1604-2022)Mckesson Medical-Surgical Inc. Corporate Office2022-08-26
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip Cath recall (Z-1159-2018)Arrow International Inc2018-03-05
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), recall (Z-1161-2018)Arrow International Inc2018-03-05
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARR recall (Z-1162-2018)Arrow International Inc2018-03-05
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARR recall (Z-1163-2018)Arrow International Inc2018-03-05
Pressure Injectable Two- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROW recall (Z-1164-2018)Arrow International Inc2018-03-05
Pressure Injectable Multi- Lumen CVC Kit recall (Z-1165-2018)Arrow International Inc2018-03-05
ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to permit venous ac recall (Z-1166-2018)Arrow International Inc2018-03-05
Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; P recall (Z-0647-2018)Arrow International Inc2018-02-20
Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kit; Pr recall (Z-0649-2018)Arrow International Inc2018-02-20
Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Cathe recall (Z-0651-2018)Arrow International Inc2018-02-20
Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; P recall (Z-0653-2018)Arrow International Inc2018-02-20
AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703-XP1A and CDC recall (Z-0655-2018)Arrow International Inc2018-02-20
Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. P recall (Z-1879-2017)Arrow International Inc2017-04-10
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER. Pr recall (Z-2136-2016)Arrow International Inc2016-07-06
ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter pe recall (Z-1082-2015)Arrow International Inc2015-02-10
Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0 recall (Z-1005-2015)Arrow International Inc2015-01-22
Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a mult recall (Z-1633-2014)Arrow International Inc2014-05-19
Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central recall (Z-1823-2012)Arrow International Inc2012-06-19
Multi-Lumen Pressure Injectable Central Venous Catheterization kit with Blue FlexTip Cathe recall (Z-2491-2010)Arrow International Inc2010-09-25