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510(k) K220280

Device
Arrow Stiffening Stylet
Applicant
Arrow International, LLC (A subsidiary of Teleflex, Inc.)
510(k) number
K220280
Product code
DRB
Decision
Substantially Equivalent (SESE)
Decision date
2022-08-30
Date received
2022-02-01
Regulation
870.1380
Classification name
Stylet, Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Fallon Young
Address
3015 Carrington Mill Blvd. Morrisville NC US 27560 27560

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DRB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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
K000955PLACER MODEL 6232 STEERABLE STYLETMedtronic Vascular2000-06-16