FDA 510(k) Applications for Medical Device Product Code: DRC (Trocar)

FDA 510(k) Applications for Medical Device Product Code "DRC"
(Trocar)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K951448	GLOBAL MEDICAL PRODUCTS, LTD.	GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE	03/27/1996
K111644	Greatbatch Medical	MOBICATH TRANSSEPTAL NEEDLE	10/03/2011
K122832	Greatbatch Medical	MOBICATH TRANSSEPTAL NEEDLE	12/19/2012
K061070	HANSEN MEDICAL, INC.	HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR	10/13/2006
K965051	HEARTPORT, INC.	HEARTPORT NEEDLE TROCAR	03/12/1997
K964302	HEARTPORT, INC.	HEARTPORT THORACIC TROCAR	05/09/1997
K011373	MEDCANICA, INC.	INSTRUMENT DAMPING PORT	10/12/2001
K011349	MEDCANICA, INC.	INTERCOSTAL LOCKABLE-DIRECTABLE PORT	10/05/2001
K974743	MEDICAL DEVICE TECHNOLOGIES, INC.	MANAN	04/06/1998
K974745	MEDICAL DEVICE TECHNOLOGIES, INC.	MANAN GWI GUIDE WIRE INTRODUCER	04/06/1998
K974742	MEDICAL DEVICE TECHNOLOGIES, INC.	MANAN POTTS-COURNAND NEEDLE	04/06/1998
K022117	MERIT MEDICAL SYSTEMS, INC.	MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5	10/11/2002
K130843	Oscor Inc.	SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE	01/08/2014
K081986	Oscor Inc.	SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE	11/14/2008
K172934	Pressure Products Medical Device Manufacturing LLC	Needle Free Transseptal Cannula	02/16/2018
K210328	Pressure Products Medical Device Manufacturing LLC	SafeSept Blunt Needle	03/05/2021
K172893	Pressure Products Medical Device Manufacturing LLC	SafeSept Needle Free Transseptal Guidewire	12/21/2017
K170671	Pressure Products Medical Device Manufacturing LLC	SafeSept Transseptal Guidewire	10/20/2017
K172950	Pressure Products Medical Device Manufacturing LLC	TSN Transseptal Needle	02/21/2018
K221707	Pressure Products Medical Device Manufacturing LLC.	SafeSept« Transseptal Guidewire (SS-140)	09/14/2022
K212625	Shanghai MicroPort EP MedTech Co., Ltd.	PathBuilder Transseptal Needle	03/23/2022
K072278	ST. JUDE MEDICAL	BRK TRANSSEPTAL NEEDLE	09/13/2007
K122587	ST. JUDE MEDICAL	BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208	02/07/2013
K132943	SYNAPTIC MEDICAL LIMITED	INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE	08/29/2014
K011727	THOMAS MEDICAL PRODUCTS, INC.	TRANSSEPTAL NEEDLE/TROCAR	05/02/2002
K022257	VOMED VOLZER MEDIZINTECHNIK GMBH & CO.	VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX	10/04/2002

FDA 510(k) Applications for Medical Device Product Code "DRC" (Trocar)

FDA 510(k) Applications for Medical Device Product Code "DRC"
(Trocar)