Armada 18 PTA Catheter

Catheter, Angioplasty, Peripheral, Transluminal

ABBOTT VASCULAR

The following data is part of a premarket notification filed by Abbott Vascular with the FDA for Armada 18 Pta Catheter.

Pre-market Notification Details

Device IDK151317
510k NumberK151317
Device Name:Armada 18 PTA Catheter
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant ABBOTT VASCULAR 3200 LAKESIDE DR Santa Clara,  CA  95054
ContactShu Chi Hsu
CorrespondentShu Chi Hsu
ABBOTT VASCULAR 3200 LAKESIDE DR Santa Clara,  CA  95054
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-18
Decision Date2015-07-06
Summary:summary

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