Product code DRC

Current FDA Classification

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

Related 510(k) Records

510(k)DeviceApplicantDecision date
K240246Accusafe Transseptal Guidewire (GTR31180, GTR31230)Synaptic Medical Corporation2024-07-26
K241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)Pressure Products Medical Device Manufacturing, LLC2024-05-17
K221707SafeSept® Transseptal Guidewire (SS-140)Pressure Products Medical Device Manufacturing, LLC2022-09-14
K212625PathBuilder Transseptal NeedleShanghai Microport EP Medtech Co., Ltd.2022-03-23
K210328SafeSept Blunt NeedlePressure Products Medical Device Manufacturing, LLC2021-03-05
K172950TSN Transseptal NeedlePressure Products Medical Device Manufacturing, LLC2018-02-21
K172934Needle Free Transseptal CannulaPressure Products Medical Device Manufacturing, LLC2018-02-16
K172893SafeSept Needle Free Transseptal GuidewirePressure Products Medical Device Manufacturing, LLC2017-12-21
K170671SafeSept Transseptal GuidewirePressure Products Medical Device Manufacturing, LLC2017-10-20
K132943INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLESynaptic Medical Limited2014-08-29
K130843SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIREOscor, Inc.2014-01-08
K122587BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208St Jude Medical2013-02-07
K122832MOBICATH TRANSSEPTAL NEEDLEGreat Batch Medical2012-12-19
K111644MOBICATH TRANSSEPTAL NEEDLEGreat Batch Medical2011-10-03
K081986SAFESEPT TRANSSEPTAL TROCAR GUIDEWIREOscor, Inc.2008-11-14
K072278BRK TRANSSEPTAL NEEDLESt Jude Medical2007-09-13
K061070HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATORHansen Medical, Inc.2006-10-13
K022117MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5Merit Medical Systems, Inc.2002-10-11
K022257VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXXVomed Volzer Medizintechnik GmbH & Co.2002-10-04
K011727TRANSSEPTAL NEEDLE/TROCARThomas Medical Products, Inc.2002-05-02
K011373INSTRUMENT DAMPING PORTMedcanica, Inc.2001-10-12
K011349INTERCOSTAL LOCKABLE-DIRECTABLE PORTMedcanica, Inc.2001-10-05
K974745MANAN GWI GUIDE WIRE INTRODUCERMedical Device Technologies, Inc.1998-04-06
K974743MANANMedical Device Technologies, Inc.1998-04-06
K974742MANAN POTTS-COURNAND NEEDLEMedical Device Technologies, Inc.1998-04-06
K964302HEARTPORT THORACIC TROCARHeartport, Inc.1997-05-09
K965051HEARTPORT NEEDLE TROCARHeartport, Inc.1997-03-12
K951448GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLEGlobal Medical Products, Ltd.1996-03-27
K936247MEDICON INSTRUMENTS TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVESMedicon Instruments, Inc.1994-05-19
K940036ENDOSURG DISPOSABLE SECONDARY TROCAREndosurg1994-05-12

Related GUDID Devices

Primary DIBrandCompanyPublished
00888867500914Arthrex®ARTHREX, INC.2026-03-13
04262494463815N/ADoppkon GmbH & Co. KG2025-09-12
04262494463846N/ADoppkon GmbH & Co. KG2025-09-12
04262494463839N/ADoppkon GmbH & Co. KG2025-09-12
04262494463822N/ADoppkon GmbH & Co. KG2025-09-12
04262494463808N/ADoppkon GmbH & Co. KG2025-09-12
04262494463792N/ADoppkon GmbH & Co. KG2025-09-12
04262494463785N/ADoppkon GmbH & Co. KG2025-09-12
04262494463631N/ADoppkon GmbH & Co. KG2025-09-12
04262494463594N/ADoppkon GmbH & Co. KG2025-09-12
04262494461064N/ADoppkon GmbH & Co. KG2025-08-05
04262494461224N/ADoppkon GmbH & Co. KG2025-08-05
04262494461156N/ADoppkon GmbH & Co. KG2025-08-04
04262494461125N/ADoppkon GmbH & Co. KG2025-08-04
04262494461132N/ADoppkon GmbH & Co. KG2025-08-04
04262494461149N/ADoppkon GmbH & Co. KG2025-08-04
04262494461118N/ADoppkon GmbH & Co. KG2025-08-04
04262494461101N/ADoppkon GmbH & Co. KG2025-08-04
04262494461095N/ADoppkon GmbH & Co. KG2025-08-04
04262494461088N/ADoppkon GmbH & Co. KG2025-08-04
04262494461071N/ADoppkon GmbH & Co. KG2025-08-04
04262494461057N/ADoppkon GmbH & Co. KG2025-08-04
04262494461040N/ADoppkon GmbH & Co. KG2025-08-04
04262494461033N/ADoppkon GmbH & Co. KG2025-08-04
04262494461026N/ADoppkon GmbH & Co. KG2025-08-04
04262494461019N/ADoppkon GmbH & Co. KG2025-08-04
20884521025438ArgyleCardinal Health, Inc.2016-09-24
20884521025421ArgyleCardinal Health, Inc.2016-09-24
20884521025414ArgyleCardinal Health, Inc.2016-09-24
20884521025407ArgyleCardinal Health, Inc.2016-09-24