Atlas FDA

MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT

FDA 510(k) clearance K011761 · decided 2001-10-31

Clearance details

K-number
K011761
Device name
MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT
Applicant
Arrow Intl., Inc.
Decision
Substantially Equivalent
Date received
2001-06-06
Decision date
2001-10-31
Days to decision
147 days
Clearance type
Traditional
Product code
DYB
Device class
2
Regulation number
870.1340
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Reading, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-0990 recall (Z-2385-2026)ARROW INTERNATIONAL, LLC2026-06-13
Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes recall (Z-2825-2015)Arrow International Inc2015-09-30
Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflu recall (Z-0066-2015)Arrow International Inc2014-10-14
MAC (TM) Two Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integ recall (Z-0783-2010)Arrow International Inc2010-03-05