STEP-TIP CHRONIC HEMODIALYSIS CATHETER

Catheter, Hemodialysis, Implanted

ARROW INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Arrow International, Inc. with the FDA for Step-tip Chronic Hemodialysis Catheter.

Pre-market Notification Details

Device IDK040666
510k NumberK040666
Device Name:STEP-TIP CHRONIC HEMODIALYSIS CATHETER
ClassificationCatheter, Hemodialysis, Implanted
Applicant ARROW INTERNATIONAL, INC. 2400 BERNVILLE RD. Reading,  PA  19605
ContactBrandon Epting
CorrespondentBrandon Epting
ARROW INTERNATIONAL, INC. 2400 BERNVILLE RD. Reading,  PA  19605
Product CodeMSD  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-03-15
Decision Date2004-05-14
Summary:summary

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