VPS Rhythm Device With TipTracker Technology

Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

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

The following data is part of a premarket notification filed by Arrow International, Inc. (a Subsidiary Of Teleflex, Inc.) with the FDA for Vps Rhythm Device With Tiptracker Technology.

Pre-market Notification Details

Device IDK160925
510k NumberK160925
Device Name:VPS Rhythm Device With TipTracker Technology
ClassificationCatheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Applicant ARROW INTERNATIONAL, INC. (A SUBSIDIARY OF TELEFLEX, INC.) 2400 BERNVILLE RD. Reading,  PA  19605
ContactKarl J. Nittinger
CorrespondentChristine Ford
ARROW INTERNATIONAL, INC. (A SUBSIDIARY OF TELEFLEX, INC.) 2400 BERNVILLE RD. Reading,  PA  19605
Product CodeLJS  
CFR Regulation Number880.5970 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-04
Decision Date2016-12-22
Summary:summary

NIH GUDID Devices

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