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DRC — Trocar Class II

FDA Device Classification

Classification Details

Product Code
DRC
Device Class
Class II
Regulation Number
870.1390
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K240246synaptic medical corporationAccusafe Transseptal Guidewire (GTR31180, GTR31230)July 26, 2024
K241042pressure products medical device manufacturingSafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)May 17, 2024
K221707pressure products medical device manufacturingSafeSept® Transseptal Guidewire (SS-140)September 14, 2022
K212625shanghai microport ep medtech coPathBuilder Transseptal NeedleMarch 23, 2022
K210328pressure products medical device manufacturingSafeSept Blunt NeedleMarch 5, 2021
K172950pressure products medical device manufacturingTSN Transseptal NeedleFebruary 21, 2018
K172934pressure products medical device manufacturingNeedle Free Transseptal CannulaFebruary 16, 2018
K172893pressure products medical device manufacturingSafeSept Needle Free Transseptal GuidewireDecember 21, 2017
K170671pressure products medical device manufacturingSafeSept Transseptal GuidewireOctober 20, 2017
K132943synaptic medical limitedINTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLEAugust 29, 2014
K130843oscorSAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIREJanuary 8, 2014
K122587st jude medicalBRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208February 7, 2013
K122832great batch medicalMOBICATH TRANSSEPTAL NEEDLEDecember 19, 2012
K111644great batch medicalMOBICATH TRANSSEPTAL NEEDLEOctober 3, 2011
K081986oscorSAFESEPT TRANSSEPTAL TROCAR GUIDEWIRENovember 14, 2008
K072278st jude medicalBRK TRANSSEPTAL NEEDLESeptember 13, 2007
K061070hansen medicalHANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOROctober 13, 2006
K022117merit medical systemsMAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHOctober 11, 2002
K022257vomed volzer medizintechnik gmbh andVOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 October 4, 2002
K011727thomas medical productsTRANSSEPTAL NEEDLE/TROCARMay 2, 2002