091 Balloon Guide Catheter

Catheter, Percutaneous

InNeuroCo Inc.

The following data is part of a premarket notification filed by Inneuroco Inc. with the FDA for 091 Balloon Guide Catheter.

Pre-market Notification Details

Device IDK220331
510k NumberK220331
Device Name:091 Balloon Guide Catheter
ClassificationCatheter, Percutaneous
Applicant InNeuroCo Inc. 19700 Stirling Road, Suite 1 Pembroke Pines,  FL  33332
ContactMarc Litzenberg
CorrespondentGarry Koroshec
InNeuroCo Inc. 19700 Stirling Road, Suite 1 Pembroke Pines,  FL  33332
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-04
Decision Date2022-07-29

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