RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP

Catheter, Percutaneous

ARROW INTL., INC.

The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Radial Artery Catherization Set With Integral Needle Protection,model Ra-04020-sp.

Pre-market Notification Details

Device IDK021120
510k NumberK021120
Device Name:RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP
ClassificationCatheter, Percutaneous
Applicant ARROW INTL., INC. 2400 BERNVILLE RD. Reading,  PA  19605
ContactDebbie Peacock
CorrespondentDebbie Peacock
ARROW INTL., INC. 2400 BERNVILLE RD. Reading,  PA  19605
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-04-08
Decision Date2002-05-02
Summary:summary

NIH GUDID Devices

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