Product Code: DRC FDA class 2 21 CFR 870.1390

Trocar

Cardiovascular

The Trocar is a cardiovascular surgical instrument with a pointed obturator used to puncture body walls or vessels, typically to create an access port for the introduction of catheters or other devices. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRC and it is regulated under 21 CFR 870.1390 within the Cardiovascular medical specialty.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code DRC in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: DRC
Device Class: FDA class 2
Regulation Number: 870.1390
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 51 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K240246	Accusafe Transseptal Guidewire (GTR31180, GTR31230)	Jul 26, 2024	Substantially Equivalent	Synaptic Medical Corporation
K241042	SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)	May 17, 2024	Substantially Equivalent	Pressure Products Medical Device Manufacturing, LLC
K221707	SafeSept® Transseptal Guidewire (SS-140)	Sep 14, 2022	Substantially Equivalent	Pressure Products Medical Device Manufacturing, LLC
K212625	PathBuilder Transseptal Needle	Mar 23, 2022	Substantially Equivalent	Shanghai Microport EP Medtech Co., Ltd.
K210328	SafeSept Blunt Needle	Mar 05, 2021	Substantially Equivalent	Pressure Products Medical Device Manufacturing, LLC
K172950	TSN Transseptal Needle	Feb 21, 2018	Substantially Equivalent	Pressure Products Medical Device Manufacturing, LLC
K172934	Needle Free Transseptal Cannula	Feb 16, 2018	Substantially Equivalent	Pressure Products Medical Device Manufacturing, LLC
K172893	SafeSept Needle Free Transseptal Guidewire	Dec 21, 2017	Substantially Equivalent	Pressure Products Medical Device Manufacturing, LLC
K170671	SafeSept Transseptal Guidewire	Oct 20, 2017	Substantially Equivalent	Pressure Products Medical Device Manufacturing, LLC
K132943	INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE	Aug 29, 2014	Substantially Equivalent	Synaptic Medical Limited
K130843	SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE	Jan 08, 2014	Substantially Equivalent	Oscor, Inc.
K122587	BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208	Feb 07, 2013	Substantially Equivalent	St Jude Medical
K122832	MOBICATH TRANSSEPTAL NEEDLE	Dec 19, 2012	Substantially Equivalent	Great Batch Medical
K111644	MOBICATH TRANSSEPTAL NEEDLE	Oct 03, 2011	Substantially Equivalent	Great Batch Medical
K081986	SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE	Nov 14, 2008	Substantially Equivalent	Oscor, Inc.
K072278	BRK TRANSSEPTAL NEEDLE	Sep 13, 2007	Substantially Equivalent	St Jude Medical
K061070	HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR	Oct 13, 2006	Substantially Equivalent	Hansen Medical, Inc.
K022117	MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5	Oct 11, 2002	Substantially Equivalent	Merit Medical Systems, Inc.
K022257	VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX	Oct 04, 2002	Substantially Equivalent	Vomed Volzer Medizintechnik GmbH & Co.
K011727	TRANSSEPTAL NEEDLE/TROCAR	May 02, 2002	Substantially Equivalent	Thomas Medical Products, Inc.
K011373	INSTRUMENT DAMPING PORT	Oct 12, 2001	Substantially Equivalent	Medcanica, Inc.
K011349	INTERCOSTAL LOCKABLE-DIRECTABLE PORT	Oct 05, 2001	Substantially Equivalent	Medcanica, Inc.
K974745	MANAN GWI GUIDE WIRE INTRODUCER	Apr 06, 1998	Substantially Equivalent	Medical Device Technologies, Inc.
K974743	MANAN	Apr 06, 1998	Substantially Equivalent	Medical Device Technologies, Inc.
K974742	MANAN POTTS-COURNAND NEEDLE	Apr 06, 1998	Substantially Equivalent	Medical Device Technologies, Inc.
K964302	HEARTPORT THORACIC TROCAR	May 09, 1997	Substantially Equivalent	Heartport, Inc.
K965051	HEARTPORT NEEDLE TROCAR	Mar 12, 1997	Substantially Equivalent	Heartport, Inc.
K951448	GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE	Mar 27, 1996	Substantially Equivalent	Global Medical Products, Ltd.
K936247	MEDICON INSTRUMENTS TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES	May 19, 1994	Substantially Equivalent	Medicon Instruments, Inc.
K940036	ENDOSURG DISPOSABLE SECONDARY TROCAR	May 12, 1994	Substantially Equivalent	Endosurg
K924338	ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE	Mar 18, 1993	Substantially Equivalent	Arrow Intl., Inc.
K913267	R-GROUP INTL. ONE WALL PUNCTURE NEEDLE	Jun 05, 1992	Substantially Equivalent	R-Group Intl.
K914985	DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION	Dec 20, 1991	Substantially Equivalent	E-Z-Em, Inc.
K911483	LAPAROSCOPIC TROCAR	Jul 02, 1991	Substantially Equivalent	United States Endoscopy Group, Inc.
K911462	SURGICAL TROCAR	Apr 22, 1991	Substantially Equivalent	Applied Medical
K900664	DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES	Jul 18, 1990	Substantially Equivalent	Sterimed, Inc.
K895455	SELDINGER PERCUTANEOUS 2 PC NEEDLES	Nov 14, 1989	Substantially Equivalent	Advance Medical Designs, Inc.
K895454	SELDINGER SINGLE WALL; STYLE I & II (FLASHBACK)	Nov 14, 1989	Substantially Equivalent	Advance Medical Designs, Inc.
K893707	AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT	Jun 15, 1989	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K890209	DISPOSABLE ANGIOGRAPHY NEEDLES	May 19, 1989	Substantially Equivalent	E-Z-Em, Inc.
K871377	NAMIC COURNAND STYLE INTRODUCER NEEDLE	May 07, 1987	Substantially Equivalent	North American Instrument Corp.
K871382	NAMIC ONE PART INTRODUCER NEEDLE	May 06, 1987	Substantially Equivalent	North American Instrument Corp.
K871378	NAMIC SELDINGER INTRODUCER NEEDLE	May 06, 1987	Substantially Equivalent	North American Instrument Corp.
K854293	MEDSURG POTT-COURNAND NEEDLE	Jan 15, 1986	Substantially Equivalent	Medsurg Industries, Inc.
K854294	MEDSURG SELDINGER NEEDLE	Jan 13, 1986	Substantially Equivalent	Medsurg Industries, Inc.
K853132	EMERSON TRO/CATH TROCAR CATHETERS	Jan 08, 1986	Substantially Equivalent	J. H. Emerson Co.
K840529	STEIGER TUNNELING INSTRUMENT 285	Mar 12, 1984	Substantially Equivalent	Evermed, Inc.
K811964	VISITEC NEEDLE RANGE (CARDIOVASCULAR)	Jul 20, 1981	Substantially Equivalent	Visitec Co.
K781221	DILUTION KIT, THERMAL, COLD PAC	Aug 23, 1978	Substantially Equivalent	Instrumentation Laboratory CO
K772369	NEEDLES USED IN ANGIOGRAPHIC PROCED.	Jan 24, 1978	Substantially Equivalent	Argon Medical Corp.
K771261	ADVANSET	Aug 16, 1977	Substantially Equivalent	C.R. Bard, Inc.