ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System

Catheter, Peripheral, Atherectomy

Cardiovascular Systems Inc.

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

Pre-market Notification Details

Device IDK180416
510k NumberK180416
Device Name:ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System
ClassificationCatheter, Peripheral, Atherectomy
Applicant Cardiovascular Systems Inc. 1225 Old Highway 8 NW Saint Paul,  MN  55112
ContactSusan Wolf
CorrespondentSusan Wolf
Cardiovascular Systems Inc. 1225 Old Highway 8 NW Saint Paul,  MN  55112
Product CodeMCW  
CFR Regulation Number870.4875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-02-15
Decision Date2018-04-17
Summary:summary

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