CG+ ARROW JACC POWERED BY ARROW VPS STYLET

Catheter, Ultrasound, Intravascular

ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.)

The following data is part of a premarket notification filed by Arrow International(subsidiary Of Teleflex Inc.) with the FDA for Cg+ Arrow Jacc Powered By Arrow Vps Stylet.

Pre-market Notification Details

Device IDK132133
510k NumberK132133
Device Name:CG+ ARROW JACC POWERED BY ARROW VPS STYLET
ClassificationCatheter, Ultrasound, Intravascular
Applicant ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) 2400 BERNVILLE RD. Reading,  PA  19605
ContactJulie Lawson
CorrespondentJulie Lawson
ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) 2400 BERNVILLE RD. Reading,  PA  19605
Product CodeOBJ  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-11
Decision Date2013-09-26
Summary:summary

NIH GUDID Devices

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