ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

ARROW INTL., INC.

The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrowgard Blue Quad-lumen Central Venous Catheter.

Pre-market Notification Details

Device IDK962577
510k NumberK962577
Device Name:ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant ARROW INTL., INC. 3000 BERNVILLE RD. Reading,  PA  19605
ContactThomas D Nickel
CorrespondentThomas D Nickel
ARROW INTL., INC. 3000 BERNVILLE RD. Reading,  PA  19605
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-01
Decision Date1997-08-21

NIH GUDID Devices

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20801902172512 K962577 000

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