Reprocessed ViewFlex™ Xtra ICE Catheter

Reprocessed Intravascular Ultrasound Catheter

Sterilmed, Inc.

The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Viewflex™ Xtra Ice Catheter.

Pre-market Notification Details

Device IDK190478
501k NumberK190478
Device Name:Reprocessed ViewFlex™ Xtra ICE Catheter
ClassificationReprocessed Intravascular Ultrasound Catheter
Applicant Sterilmed, Inc. 5010 Cheshire Pkwy N, Suite 2 Plymouth,  MN  55446
ContactJan Flegeau
CorrespondentJan Flegeau
Sterilmed, Inc. 5010 Cheshire Pkwy N, Suite 2 Plymouth,  MN  55446
Product CodeOWQ  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
501k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-27
Decision Date2019-11-14

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