1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP

Catheter, Peripheral, Atherectomy

ATHEROMED INC

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

Pre-market Notification Details

Device IDK140944
510k NumberK140944
Device Name:1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP
ClassificationCatheter, Peripheral, Atherectomy
Applicant ATHEROMED INC 1455 ADAMS DRIVE SUITE 1120 Menlo Park,  CA  94025
ContactJean Chang
CorrespondentJean Chang
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 Received2014-04-14
Decision Date2014-08-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00845225003562 K140944 000
00845225003548 K140944 000
00845225003494 K140944 000
00845225003470 K140944 000

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