510(k) K014109

Device
IN-TIME RETRIEVAL DEVICE
Applicant
BOSTON SCIENTIFIC, TARGET
510(k) number
K014109
Product code
MMX  
Decision
Substantially Equivalent (SESE)
Decision date
2002-03-12
Date received
2001-12-14
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
SETH A SCHULMAN
Address
47900 Bayside Pkwy. Fremont CA US 94538 94538

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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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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