DRC · Class II · 21 CFR 870.1390

FDA Product Code DRC: Trocar

Leading manufacturers include Pressure Products Medical Device Manufacturing, LLC, North American Instrument Corp. and Medical Device Technologies, Inc..

51
Total
51
Cleared
123d
Avg days
1977
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Trocar Devices (Product Code DRC)

51 devices
1–24 of 51
Cleared Jul 26, 2024
Accusafe Transseptal Guidewire (GTR31180, GTR31230)
K240246
Synaptic Medical Corporation
Cardiovascular · 178d
Cleared May 17, 2024
SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)
K241042
Pressure Products Medical Device Manufacturing, LLC
Cardiovascular · 30d
Cleared Sep 14, 2022
SafeSept® Transseptal Guidewire (SS-140)
K221707
Pressure Products Medical Device Manufacturing, LLC
Cardiovascular · 93d
Cleared Mar 23, 2022
PathBuilder Transseptal Needle
K212625
Shanghai Microport EP Medtech Co., Ltd.
Cardiovascular · 217d
Cleared Mar 05, 2021
SafeSept Blunt Needle
K210328
Pressure Products Medical Device Manufacturing, LLC
Cardiovascular · 29d
Cleared Feb 21, 2018
TSN Transseptal Needle
K172950
Pressure Products Medical Device Manufacturing, LLC
Cardiovascular · 148d
Cleared Feb 16, 2018
Needle Free Transseptal Cannula
K172934
Pressure Products Medical Device Manufacturing, LLC
Cardiovascular · 144d
Cleared Dec 21, 2017
SafeSept Needle Free Transseptal Guidewire
K172893
Pressure Products Medical Device Manufacturing, LLC
Cardiovascular · 90d
Cleared Oct 20, 2017
SafeSept Transseptal Guidewire
K170671
Pressure Products Medical Device Manufacturing, LLC
Cardiovascular · 228d
Cleared Aug 29, 2014
INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE
K132943
Synaptic Medical Limited
Cardiovascular · 344d
Cleared Jan 08, 2014
SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE
K130843
Oscor, Inc.
Cardiovascular · 287d
Cleared Feb 07, 2013
BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208
K122587
St Jude Medical
Cardiovascular · 167d
Cleared Dec 19, 2012
MOBICATH TRANSSEPTAL NEEDLE
K122832
Great Batch Medical
Cardiovascular · 93d
Cleared Oct 03, 2011
MOBICATH TRANSSEPTAL NEEDLE
K111644
Great Batch Medical
Cardiovascular · 112d
Cleared Nov 14, 2008
SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE
K081986
Oscor, Inc.
Cardiovascular · 123d
Cleared Sep 13, 2007
BRK TRANSSEPTAL NEEDLE
K072278
St Jude Medical
Cardiovascular · 28d
Cleared Oct 11, 2002
MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5
K022117
Merit Medical Systems, Inc.
Cardiovascular · 102d
Cleared May 02, 2002
TRANSSEPTAL NEEDLE/TROCAR
K011727
Thomas Medical Products, Inc.
Cardiovascular · 332d
Cleared Apr 06, 1998
MANAN POTTS-COURNAND NEEDLE
K974742
Medical Device Technologies, Inc.
Cardiovascular · 108d
Cleared Apr 06, 1998
MANAN
K974743
Medical Device Technologies, Inc.
Cardiovascular · 108d
Cleared Apr 06, 1998
MANAN GWI GUIDE WIRE INTRODUCER
K974745
Medical Device Technologies, Inc.
Cardiovascular · 108d
Cleared May 09, 1997
HEARTPORT THORACIC TROCAR
K964302
Heartport, Inc.
Cardiovascular · 192d
Cleared Mar 12, 1997
HEARTPORT NEEDLE TROCAR
K965051
Heartport, Inc.
Cardiovascular · 84d
Cleared Mar 27, 1996
GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE
K951448
Global Medical Products, Ltd.
Cardiovascular · 364d

About Product Code DRC - Regulatory Context

510(k) Submission Activity

51 total 510(k) submissions under product code DRC since 1977, with 51 receiving FDA clearance (average review time: 123 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.