2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System

Catheter, Peripheral, Atherectomy

Volcano AtheroMed, Inc.

The following data is part of a premarket notification filed by Volcano Atheromed, Inc. with the FDA for 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System.

Pre-market Notification Details

Device IDK211518
510k NumberK211518
Device Name:2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System
ClassificationCatheter, Peripheral, Atherectomy
Applicant Volcano AtheroMed, Inc. 1530 O'Brien Drive, Suite A Menlo Park,  CA  94025
ContactJean Chang
CorrespondentJean Chang
Volcano AtheroMed, Inc. 1530 O'Brien Drive, Suite A Menlo Park,  CA  94025
Product CodeMCW  
CFR Regulation Number870.4875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-17
Decision Date2021-06-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00845225003197 K211518 000
00845225003180 K211518 000
00845225003173 K211518 000
00845225003166 K211518 000
00845225003593 K211518 000
00845225003531 K211518 000
00845225003524 K211518 000
00845225003463 K211518 000

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