VERRATA 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 Pressure Guide Wire.

Pre-market Notification Details

Device IDK131288
510k NumberK131288
Device Name:VERRATA PRESSURE GUIDE WIRE
ClassificationWire, Guide, Catheter
Applicant VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova,  CA  95670
ContactJwala Jawharkar
CorrespondentJwala Jawharkar
VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova,  CA  95670
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-06
Decision Date2013-06-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00845225002466 K131288 000
00845225002459 K131288 000
00845225002442 K131288 000
00845225002435 K131288 000

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