ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520

Catheter, Percutaneous

ARROW INTL., INC.

The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow Seldinger Arterial Catherization Devices, Models Ex Sac 00520.

Pre-market Notification Details

Device IDK093050
510k NumberK093050
Device Name:ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520
ClassificationCatheter, Percutaneous
Applicant ARROW INTL., INC. 2400 BERNVILLE RD. Reading,  PA  19605
ContactChristine Ford
CorrespondentChristine Ford
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 Received2009-09-30
Decision Date2009-12-18
Summary:summary

NIH GUDID Devices

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