ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT

Catheter, Subclavian

ARROW INTL., INC.

The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow Large-bore Dual Lumen Hemodialysis Kit.

Pre-market Notification Details

Device IDK895417
510k NumberK895417
Device Name:ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT
ClassificationCatheter, Subclavian
Applicant ARROW INTL., INC. P.O. BOX 6306 HILL AND GEORGE AVENUES Reading,  PA  19610
ContactThomas D Nickel
CorrespondentThomas D Nickel
ARROW INTL., INC. P.O. BOX 6306 HILL AND GEORGE AVENUES Reading,  PA  19610
Product CodeLFJ  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-09-01
Decision Date1990-01-03

NIH GUDID Devices

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