SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300

Catheter, Peripheral, Atherectomy

FOX HOLLOW TECHNOLOGIES

The following data is part of a premarket notification filed by Fox Hollow Technologies with the FDA for Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706, 04300.

Pre-market Notification Details

Device IDK043553
510k NumberK043553
Device Name:SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300
ClassificationCatheter, Peripheral, Atherectomy
Applicant FOX HOLLOW TECHNOLOGIES 300 SAGINAW DR. Redwood City,  CA  94063
ContactMelissa Murphy
CorrespondentMelissa Murphy
FOX HOLLOW TECHNOLOGIES 300 SAGINAW DR. Redwood City,  CA  94063
Product CodeMCW  
CFR Regulation Number870.4875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-12-27
Decision Date2005-02-18
Summary:summary

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