Atlas FDA

ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER

FDA 510(k) clearance K993691 · decided 2000-03-08

Clearance details

K-number
K993691
Device name
ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
Applicant
Arrow Intl., Inc.
Decision
Substantially Equivalent
Date received
1999-11-01
Decision date
2000-03-08
Days to decision
128 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
ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard recall (Z-1152-2018)Arrow International Inc2018-03-21
ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code: AK-45703-ACD recall (Z-0656-2018)Arrow International Inc2018-02-20
Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK recall (Z-1507-2014)Arrow International Inc2014-04-24
Two-Lumen Central Venous Catheterization kit with Blue FlexTip ARROW g+ard Blue PLUS Cathe recall (Z-2493-2010)Arrow International Inc2010-09-25
Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS recall (Z-0785-2010)Arrow International Inc2010-03-05
Two-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS ( recall (Z-0786-2010)Arrow International Inc2010-03-05
Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS recall (Z-0787-2010)Arrow International Inc2010-03-05
Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS recall (Z-0788-2010)Arrow International Inc2010-03-05
Arrow ARROWg+ard Blue Plus Multi-Lumen CVCs (Central Venous Catheters) recall (Z-1498-2009)Arrow International Inc2009-06-24
Arrowg+ard Blue Two Lumen CVC Super Kit, Catalog number AK-22802-SK. The kit actually cont recall (Z-0059-05)Arrow International Inc2004-10-28