Flextra Steerable Introducer

Introducer, Catheter

Rhythm Xience, Inc. (RXI)

The following data is part of a premarket notification filed by Rhythm Xience, Inc. (rxi) with the FDA for Flextra Steerable Introducer.

Pre-market Notification Details

Device IDK170373
510k NumberK170373
Device Name:Flextra Steerable Introducer
ClassificationIntroducer, Catheter
Applicant Rhythm Xience, Inc. (RXI) 10025 Valley View Road, Suite 130 Eden Prairie,  MN  55344
ContactJames Hassett
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2017-02-07
Decision Date2017-02-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00852392007019 K170373 000
00852392007002 K170373 000

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