510(k) K152136

Device
Recovery Cone Removal System
Applicant
C.R. Bard, Inc.
510(k) number
K152136
Product code
MMX  
Decision
Substantially Equivalent (SESE)
Decision date
2016-02-18
Date received
2015-07-31
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
No

Applicant Contact#

Contact
Joni Creal
Address
1625 W Third St. Tempe AZ US 85281 85281

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
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K232443Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitArgon Medical Devices, Inc.2023-09-07
K222254Gunther Tulip Vena Cava Filter Retrieval SetCook Incorporated2023-05-16
K222083LimFlow V-CeiverLimFlow, Inc.2022-08-09
K212988ONO Retrieval DeviceOnocor Vascular, LLC2022-05-23
K213494Aveir Retrieval CatheterABBOTT MEDICAL2022-04-01
K200963Halo Single-Loop Microsnare KitArgon Medical Devices, Inc.2021-01-05
K200268Halo™ Single-Loop Snare KitArgon Medical Devices, Inc.2020-06-03
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

Legacy Summary#

summary

FDA Review#

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