Verrata PLUS Pressure Guide Wire

Wire, Guide, Catheter

Volcano Corporation

The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Verrata Plus Pressure Guide Wire.

Pre-market Notification Details

Device IDK210235
510k NumberK210235
Device Name:Verrata PLUS Pressure Guide Wire
ClassificationWire, Guide, Catheter
Applicant Volcano Corporation 3721 Valley Centre Drive, Ste 500 San Diego,  CA  92130
ContactLeilani Taylor
CorrespondentLeilani Taylor
Volcano Corporation 3721 Valley Centre Drive, Ste 500 San Diego,  CA  92130
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-28
Decision Date2021-04-15

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