Product code DRC

Device name: Trocar
Medical specialty: Cardiovascular
Device class: 2
Regulation number: 870.1390
Review panel: CV
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K240246	Accusafe Transseptal Guidewire (GTR31180, GTR31230)	Synaptic Medical Corporation	2024-07-26
K241042	SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)	Pressure Products Medical Device Manufacturing, LLC	2024-05-17
K221707	SafeSept® Transseptal Guidewire (SS-140)	Pressure Products Medical Device Manufacturing, LLC	2022-09-14
K212625	PathBuilder Transseptal Needle	Shanghai Microport EP Medtech Co., Ltd.	2022-03-23
K210328	SafeSept Blunt Needle	Pressure Products Medical Device Manufacturing, LLC	2021-03-05
K172950	TSN Transseptal Needle	Pressure Products Medical Device Manufacturing, LLC	2018-02-21
K172934	Needle Free Transseptal Cannula	Pressure Products Medical Device Manufacturing, LLC	2018-02-16
K172893	SafeSept Needle Free Transseptal Guidewire	Pressure Products Medical Device Manufacturing, LLC	2017-12-21
K170671	SafeSept Transseptal Guidewire	Pressure Products Medical Device Manufacturing, LLC	2017-10-20
K132943	INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE	Synaptic Medical Limited	2014-08-29
K130843	SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE	Oscor, Inc.	2014-01-08
K122587	BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208	St Jude Medical	2013-02-07
K122832	MOBICATH TRANSSEPTAL NEEDLE	Great Batch Medical	2012-12-19
K111644	MOBICATH TRANSSEPTAL NEEDLE	Great Batch Medical	2011-10-03
K081986	SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE	Oscor, Inc.	2008-11-14
K072278	BRK TRANSSEPTAL NEEDLE	St Jude Medical	2007-09-13
K061070	HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR	Hansen Medical, Inc.	2006-10-13
K022117	MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5	Merit Medical Systems, Inc.	2002-10-11
K022257	VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX	Vomed Volzer Medizintechnik GmbH & Co.	2002-10-04
K011727	TRANSSEPTAL NEEDLE/TROCAR	Thomas Medical Products, Inc.	2002-05-02
K011373	INSTRUMENT DAMPING PORT	Medcanica, Inc.	2001-10-12
K011349	INTERCOSTAL LOCKABLE-DIRECTABLE PORT	Medcanica, Inc.	2001-10-05
K974745	MANAN GWI GUIDE WIRE INTRODUCER	Medical Device Technologies, Inc.	1998-04-06
K974743	MANAN	Medical Device Technologies, Inc.	1998-04-06
K974742	MANAN POTTS-COURNAND NEEDLE	Medical Device Technologies, Inc.	1998-04-06
K964302	HEARTPORT THORACIC TROCAR	Heartport, Inc.	1997-05-09
K965051	HEARTPORT NEEDLE TROCAR	Heartport, Inc.	1997-03-12
K951448	GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE	Global Medical Products, Ltd.	1996-03-27
K936247	MEDICON INSTRUMENTS TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES	Medicon Instruments, Inc.	1994-05-19
K940036	ENDOSURG DISPOSABLE SECONDARY TROCAR	Endosurg	1994-05-12

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
H787065076030	Embosafe	ANGIODYNAMICS, INC.	2016-09-20
H787065110090	Micro Access	ANGIODYNAMICS, INC.	2016-09-20
H787065110080	Micro Access	ANGIODYNAMICS, INC.	2016-09-20
H787065110070	Micro Access	ANGIODYNAMICS, INC.	2016-09-20
H787065110060	Micro Access	ANGIODYNAMICS, INC.	2016-09-20
H787065110040	Micro Access	ANGIODYNAMICS, INC.	2016-09-20
H787065110030	Micro Access	ANGIODYNAMICS, INC.	2016-09-20
H787065099450	Micro Access	ANGIODYNAMICS, INC.	2016-09-20
H787065099220	Micro Access	ANGIODYNAMICS, INC.	2016-09-20
H787065099090	Micro Access	ANGIODYNAMICS, INC.	2016-09-20
H787065086020	Micro Access	ANGIODYNAMICS, INC.	2016-09-20
H787065086010	Micro Access	ANGIODYNAMICS, INC.	2016-09-20
H787065084040	Morpheus	ANGIODYNAMICS, INC.	2016-09-20
H787065084030	Morpheus	ANGIODYNAMICS, INC.	2016-09-20
H787065084020	Morpheus	ANGIODYNAMICS, INC.	2016-09-20
H787065068010	Micro Access	ANGIODYNAMICS, INC.	2016-09-20
H787065076020	Embosafe	ANGIODYNAMICS, INC.	2016-09-20
H787065076010	Embosafe	ANGIODYNAMICS, INC.	2016-09-20
H787065072130	Morpheus	ANGIODYNAMICS, INC.	2016-09-20
H787065072120	Morpheus	ANGIODYNAMICS, INC.	2016-09-20
H787065072110	Morpheus	ANGIODYNAMICS, INC.	2016-09-20
H787065072100	Morpheus	ANGIODYNAMICS, INC.	2016-09-20
H787065072040	Micro Access	ANGIODYNAMICS, INC.	2016-09-20
H787065072030	Micro Access	ANGIODYNAMICS, INC.	2016-09-20
H787065072020	Micro Access	ANGIODYNAMICS, INC.	2016-09-20
H787065072010	Micro Access	ANGIODYNAMICS, INC.	2016-09-20
H787065068050	Micro Access	ANGIODYNAMICS, INC.	2016-09-20
H787065068040	Micro Access	ANGIODYNAMICS, INC.	2016-09-20
H787065068030	Micro Access	ANGIODYNAMICS, INC.	2016-09-20
H787065068020	Micro Access	ANGIODYNAMICS, INC.	2016-09-20

Product code DRC

Related 510(k) Records#

Related GUDID Devices#