510(k) K251376

Device
LimFlow ARC
Applicant
LimFlow, Inc.
510(k) number
K251376
Product code
PDU
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-31
Date received
2025-05-02
Regulation
870.1250
Classification name
Catheter For Crossing Total Occlusions
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Haley Ritchie
Address
6001 Oak Canyon Suite 100 Irvine CA US 92618 92618

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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