ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD

Catheter, Peripheral, Atherectomy

Cardiovascular System, Inc.

The following data is part of a premarket notification filed by Cardiovascular System, Inc. with the FDA for Viperwire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital Pad.

Pre-market Notification Details

Device IDK151260
510k NumberK151260
Device Name:ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD
ClassificationCatheter, Peripheral, Atherectomy
Applicant Cardiovascular System, Inc. 1228 Old Highway 8 NW Saint Paul,  MN  55112
ContactKim Wallner
CorrespondentKim Wallner
Cardiovascular System, Inc. 1228 Old Highway 8 NW Saint Paul,  MN  55112
Product CodeMCW  
CFR Regulation Number870.4875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-12
Decision Date2015-06-10
Summary:summary

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