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DRB — Stylet, Catheter Class II

FDA Device Classification

Classification Details

Product Code
DRB
Device Class
Class II
Regulation Number
870.1380
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K220280arrow international, llc (a subsidiary of teleflex, inc.)Arrow Stiffening StyletAugust 30, 2022
K191469biotronikBiotronik StyletsAugust 1, 2019
K182660galt medicalGaltTWSMay 30, 2019
K170298cook incorporatedLiberator Beacon Tip Locking StyletOctober 18, 2017
K142116spectraneticsLLD EZAugust 12, 2014
K090163st jude medicalSTYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078April 1, 2009
K080924st. jude medical, cardiac rhythm management divisiMOND RVOT STYLET MODELS 4140, 4141, 4150, 4151April 30, 2008
K072864st. jude medical, cardiac rhythm management divisiST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEMMarch 13, 2008
K053019guidant corporationACUITY STEERABLE STYLET ACCESSORYMarch 3, 2006
K052965guidant corporationEASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.February 13, 2006
K043401spectraneticsSPECTRANETICS LLD CS, MODEL 518-039March 16, 2005
K040001synovis surgical innovationsSTEERABLE STYLETMarch 9, 2004
K010906medtronic vascularMEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254April 5, 2001
K003535medtronic vascularSTYLET KIT, MODELS 6254,6282,6293February 8, 2001
K002534eupalamusEUPALAMUS DEFLECTABLE STYLET, MODEL 01545October 18, 2000
K000955medtronic vascularPLACER MODEL 6232 STEERABLE STYLETJune 16, 2000
K000366accufix research instituteFIXATION STYLETS, MODELS 335-287 AND 335-288April 14, 2000
K992664tfx medical groupTFX MEDICAL STYLET CATHETERApril 13, 2000
K993376endocardial solutionsENSTYLET MODELS EC0010, EC0020January 5, 2000
K992863guidantLEAD STYLET,MODELS 6505,6506,6507,6508November 12, 1999