LimFlow ARC

Catheter For Crossing Total Occlusions

LimFlow, Inc.

The following data is part of a premarket notification filed by Limflow, Inc. with the FDA for Limflow Arc.

Pre-market Notification Details

Device IDK221541
510k NumberK221541
Device Name:LimFlow ARC
ClassificationCatheter For Crossing Total Occlusions
Applicant LimFlow, Inc. 3031 Tisch Way - 110 Plaza West San Jose,  CA  95128
ContactZachary Woodson
CorrespondentZachary Woodson
LimFlow, Inc. 3031 Tisch Way - 110 Plaza West San Jose,  CA  95128
Product CodePDU  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-27
Decision Date2022-08-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850041730011 K221541 000
00850041730158 K221541 000

Trademark Results [LimFlow ARC]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LIMFLOW ARC
LIMFLOW ARC
79323331 not registered Live/Pending
LimFlow SA
2021-08-03

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