Steerable Guide Catheter

Catheter, Steerable

Abbott Vascular

The following data is part of a premarket notification filed by Abbott Vascular with the FDA for Steerable Guide Catheter.

Pre-market Notification Details

Device IDK172394
510k NumberK172394
Device Name:Steerable Guide Catheter
ClassificationCatheter, Steerable
Applicant Abbott Vascular 3200 Lakeside Drive Santa Clara,  CA  95054
ContactMakena Mc Gowan
CorrespondentMakena Mc Gowan
Abbott Vascular 3200 Lakeside Drive Santa Clara,  CA  95054
Product CodeDRA  
CFR Regulation Number870.1280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-08
Decision Date2017-09-06
Summary:summary

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