FDA.reportPublic FDA data

510(k) K222083

Device
LimFlow V-Ceiver
Applicant
LimFlow, Inc.
510(k) number
K222083
Product code
MMX
Decision
Substantially Equivalent (SESE)
Decision date
2022-08-09
Date received
2022-07-15
Regulation
870.5150
Classification name
Device, Percutaneous Retrieval
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes

Applicant Contact#

Contact
Zachary Woodson
Address
3031 Tisch Way - 110 Plz. W. San Jose CA US 95128 95128

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MMX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242776LimFlow V-CeiverLimFlow, Inc.2025-02-14
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K193507Merit ONE Snare SystemMerit Medical Systems, Inc.2020-01-17
K191758Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitArgon Medical Devices, Inc.2019-12-17
K181757Günther Tulip® Vena Cava Filter Retrieval SetCook Incorporated2018-11-06
K170987Captus Vascular Retrieval SystemAvantec Vascular Corporation2017-08-28
K163307Expro Elite Snare, Sympro Elite SnareVascular Solutions, Inc.2017-03-08
K160593Indy OTW Vascular RetrieverCook Incorporated2016-09-02
K152136Recovery Cone Removal SystemC.R. Bard, Inc.2016-02-18