SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

Catheter, Peripheral, Atherectomy

FOXHOLLOW TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Foxhollow Technologies, Inc. with the FDA for Silverhawk Peripheral Plaque Excision System.

Pre-market Notification Details

Device IDK061188
510k NumberK061188
Device Name:SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
ClassificationCatheter, Peripheral, Atherectomy
Applicant FOXHOLLOW TECHNOLOGIES, INC. 740 BAY ROAD Redwood City,  CA  94063
ContactMelissa S Murphy
CorrespondentMelissa S Murphy
FOXHOLLOW TECHNOLOGIES, INC. 740 BAY ROAD Redwood City,  CA  94063
Product CodeMCW  
CFR Regulation Number870.4875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-28
Decision Date2006-10-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821684074176 K061188 000
00821684074169 K061188 000
00821684074145 K061188 000
00821684074121 K061188 000
00821684074107 K061188 000
00821684074084 K061188 000
00821684074060 K061188 000
00821684074046 K061188 000
00821684074039 K061188 000

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