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510(k) K000366

Device
FIXATION STYLETS, MODELS 335-287 AND 335-288
Applicant
ACCUFIX RESEARCH INSTITUTE
510(k) number
K000366
Product code
DRB  
Decision
Substantially Equivalent (SESE)
Decision date
2000-04-14
Date received
2000-02-04
Regulation
870.1380
Classification name
Stylet, Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MICHAEL J ANDREWS
Address
12503 E. Euclid Dr. # 20 Englewood CO US 80111 80111

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DRB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K220280Arrow Stiffening StyletArrow International, LLC (A subsidiary of Teleflex, Inc.)2022-08-30
K191469Biotronik StyletsBiotronik, Inc.2019-08-01
K182660GaltTWSGalt Medical Corp.2019-05-30
K170298Liberator Beacon Tip Locking StyletCook Incorporated2017-10-18
K142116LLD EZSpectranetics, Inc.2014-08-12
K090163STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078St Jude Medical2009-04-01
K080924MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151St. Jude Medical, Cardiac Rhythm Management Divisi2008-04-30
K072864ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEMSt. Jude Medical, Cardiac Rhythm Management Divisi2008-03-13
K053019ACUITY STEERABLE STYLET ACCESSORYGuidant Corporation2006-03-03
K052965EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.Guidant Corporation2006-02-13
K043401SPECTRANETICS LLD CS, MODEL 518-039Spectranetics Corp.2005-03-16
K040001STEERABLE STYLETSynovis Surgical Innovations2004-03-09
K010906MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254Medtronic Vascular2001-04-05
K003535STYLET KIT, MODELS 6254,6282,6293Medtronic Vascular2001-02-08
K002534EUPALAMUS DEFLECTABLE STYLET, MODEL 01545Eupalamus, LLC2000-10-18

Legacy Summary#

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FDA Review#

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