KITTYCAT CATHETER, KITTYCAT 2 CATHETER

Catheter For Crossing Total Occlusions

AVINGER, INC.

The following data is part of a premarket notification filed by Avinger, Inc. with the FDA for Kittycat Catheter, Kittycat 2 Catheter.

Pre-market Notification Details

Device IDK120273
510k NumberK120273
Device Name:KITTYCAT CATHETER, KITTYCAT 2 CATHETER
ClassificationCatheter For Crossing Total Occlusions
Applicant AVINGER, INC. 755 N. MATHILDA AVENUE STE 100 Sunnyvale,  CA  94085
ContactAlbert Boniske
CorrespondentAlbert Boniske
AVINGER, INC. 755 N. MATHILDA AVENUE STE 100 Sunnyvale,  CA  94085
Product CodePDU  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-30
Decision Date2012-03-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851354004059 K120273 000

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