Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series

Catheter, Peripheral, Atherectomy

Cardiovascualr Systems Inc.

The following data is part of a premarket notification filed by Cardiovascualr Systems Inc. with the FDA for Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series.

Pre-market Notification Details

Device IDK220568
510k NumberK220568
Device Name:Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
ClassificationCatheter, Peripheral, Atherectomy
Applicant Cardiovascualr Systems Inc. 1225 Old Highway 8 NW New Brighton,  MN  55112
ContactKris Miller
CorrespondentKris Miller
Cardiovascualr Systems Inc. 1225 Old Highway 8 NW New Brighton,  MN  55112
Product CodeMCW  
CFR Regulation Number870.4875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-28
Decision Date2022-04-27

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