FOX SV PTA CATHETER

Catheter, Angioplasty, Peripheral, Transluminal

ABBOTT LABORATORIES

The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Fox Sv Pta Catheter.

Pre-market Notification Details

Device IDK072824
510k NumberK072824
Device Name:FOX SV PTA CATHETER
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant ABBOTT LABORATORIES 3200 Lakeside Drive Santa Clara,  CA  95054
ContactGeorge J Prendergast
CorrespondentGeorge J Prendergast
ABBOTT LABORATORIES 3200 Lakeside Drive Santa Clara,  CA  95054
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-10-02
Decision Date2007-10-23
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.