GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)

Angioscope

W.L. GORE & ASSOCIATES,INC

The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore Angioscopic Valvvlotome Kit (tbd).

Pre-market Notification Details

Device IDK964061
510k NumberK964061
Device Name:GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)
ClassificationAngioscope
Applicant W.L. GORE & ASSOCIATES,INC 1505 N. FOURTH ST. P.O. BOX 3000 Flagstaff,  AZ  86003 -3000
ContactDawn Lopez
CorrespondentDawn Lopez
W.L. GORE & ASSOCIATES,INC 1505 N. FOURTH ST. P.O. BOX 3000 Flagstaff,  AZ  86003 -3000
Product CodeLYK  
Subsequent Product CodeFPA
Subsequent Product CodeMGZ
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-10-10
Decision Date1997-02-20
Summary:summary

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