OCCLUSION BALLOON CATHETER

Catheter, Percutaneous

SENTREHEART INC.

The following data is part of a premarket notification filed by Sentreheart Inc. with the FDA for Occlusion Balloon Catheter.

Pre-market Notification Details

Device IDK070126
510k NumberK070126
Device Name:OCCLUSION BALLOON CATHETER
ClassificationCatheter, Percutaneous
Applicant SENTREHEART INC. 2468 EMBARCADERO WAY Palo Alto,  CA  94303
ContactLinda Guthrie
CorrespondentLinda Guthrie
SENTREHEART INC. 2468 EMBARCADERO WAY Palo Alto,  CA  94303
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-16
Decision Date2008-02-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00818354017571 K070126 000
30840143901700 K070126 000
30840143903667 K070126 000
30840143909409 K070126 000
M95520060 K070126 000

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