Arrow Endurance Extended Dwell Peripheral Catheter System

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.)

The following data is part of a premarket notification filed by Arrow International, Inc. (subsidiary Of Teleflex Inc.) with the FDA for Arrow Endurance Extended Dwell Peripheral Catheter System.

Pre-market Notification Details

Device IDK152272
510k NumberK152272
Device Name:Arrow Endurance Extended Dwell Peripheral Catheter System
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.) 2400 BERNVILLE RD Reading,  PA  19605
ContactTracy Larish
CorrespondentTracy Larish
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.) 2400 BERNVILLE RD Reading,  PA  19605
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-12
Decision Date2015-11-23
Summary:summary

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