Diamondback 360 Peripheral Orbital 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 Diamondback 360 Peripheral Orbital Atherectomy System.

Pre-market Notification Details

Device IDK152694
510k NumberK152694
Device Name:Diamondback 360 Peripheral Orbital Atherectomy System
ClassificationCatheter, Peripheral, Atherectomy
Applicant Cardiovascular Systems Inc. 1225 Old Highway 8 NW Saint Paul,  MN  55112
ContactKim Wallner
CorrespondentKim Wallner
Cardiovascular Systems Inc. 1225 Old Highway 8 NW Saint Paul,  MN  55112
Product CodeMCW  
CFR Regulation Number870.4875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-21
Decision Date2015-10-21

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