1.8mm X 149 Cm Phoenix Atherectomy Catheter, 2.2mm X 149 Cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip

Catheter, Peripheral, Atherectomy

Volcano AtheroMed, Inc.

The following data is part of a premarket notification filed by Volcano Atheromed, Inc. with the FDA for 1.8mm X 149 Cm Phoenix Atherectomy Catheter, 2.2mm X 149 Cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip.

Pre-market Notification Details

Device IDK143328
510k NumberK143328
Device Name:1.8mm X 149 Cm Phoenix Atherectomy Catheter, 2.2mm X 149 Cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip
ClassificationCatheter, Peripheral, Atherectomy
Applicant Volcano AtheroMed, Inc. 1455 Adams Drive, Suite 1120 Menlo Park,  CA  94025
ContactJean Chang
CorrespondentJean Chang
Volcano AtheroMed, Inc. 1455 Adams Drive, Suite 1120 Menlo Park,  CA  94025
Product CodeMCW  
CFR Regulation Number870.4875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-20
Decision Date2014-12-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00845225002732 K143328 000
00845225002725 K143328 000
00845225002657 K143328 000
00845225002640 K143328 000
00845225003579 K143328 000
00845225003555 K143328 000
00845225003500 K143328 000
00845225003487 K143328 000

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