MitraClip G4 Steerable Guide Catheter

Catheter, Steerable

Abbott

The following data is part of a premarket notification filed by Abbott with the FDA for Mitraclip G4 Steerable Guide Catheter.

Pre-market Notification Details

Device IDK190167
510k NumberK190167
Device Name:MitraClip G4 Steerable Guide Catheter
ClassificationCatheter, Steerable
Applicant Abbott 3200 Lakeside Drive Santa Clara,  CA  95054
ContactEkta Lad
CorrespondentEkta Lad
Abbott 3200 Lakeside Drive Santa Clara,  CA  95054
Product CodeDRA  
CFR Regulation Number870.1280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-01-31
Decision Date2019-05-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08717648231025 K190167 000

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