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Trocar

FDA product code DRC · 49 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.1390
Review panel: CV
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-08-16 – 2024-07-26

DRC 2024-07-26

Accusafe Transseptal Guidewire (GTR31180, GTR31230)

Applicant Synaptic Medical Corporation

K number K240246

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DRC 2024-05-17

SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)

Applicant Pressure Products Medical Device Manufacturing, LLC

K number K241042

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DRC 2022-09-14

SafeSept® Transseptal Guidewire (SS-140)

Applicant Pressure Products Medical Device Manufacturing, LLC

K number K221707

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DRC 2022-03-23

PathBuilder Transseptal Needle

Applicant Shanghai Microport EP Medtech Co., Ltd.

K number K212625

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DRC 2021-03-05

SafeSept Blunt Needle

Applicant Pressure Products Medical Device Manufacturing, LLC

K number K210328

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DRC 2018-02-21

TSN Transseptal Needle

Applicant Pressure Products Medical Device Manufacturing, LLC

K number K172950

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DRC 2018-02-16

Needle Free Transseptal Cannula

Applicant Pressure Products Medical Device Manufacturing, LLC

K number K172934

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DRC 2017-12-21

SafeSept Needle Free Transseptal Guidewire

Applicant Pressure Products Medical Device Manufacturing, LLC

K number K172893

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DRC 2017-10-20

SafeSept Transseptal Guidewire

Applicant Pressure Products Medical Device Manufacturing, LLC

K number K170671

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DRC 2013-02-07

BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208

Applicant St Jude Medical

K number K122587

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DRC 2012-12-19

MOBICATH TRANSSEPTAL NEEDLE

Applicant Great Batch Medical

K number K122832

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DRC 2011-10-03

MOBICATH TRANSSEPTAL NEEDLE

Applicant Great Batch Medical

K number K111644

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DRC 2008-11-14

SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE

Applicant Oscor, Inc.

K number K081986

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DRC 2007-09-13

BRK TRANSSEPTAL NEEDLE

Applicant St Jude Medical

K number K072278

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DRC 2006-10-13

HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR

Applicant Hansen Medical, Inc.

K number K061070

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DRC 2002-10-11

MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5

Applicant Merit Medical Systems, Inc.

K number K022117

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DRC 2002-10-04

VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX

Applicant Vomed Volzer Medizintechnik GmbH & Co.

K number K022257

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DRC 2002-05-02

TRANSSEPTAL NEEDLE/TROCAR

Applicant Thomas Medical Products, Inc.

K number K011727

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DRC 2001-10-12

INSTRUMENT DAMPING PORT

Applicant Medcanica, Inc.

K number K011373

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DRC 2001-10-05

INTERCOSTAL LOCKABLE-DIRECTABLE PORT

Applicant Medcanica, Inc.

K number K011349

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DRC 1998-04-06

MANAN GWI GUIDE WIRE INTRODUCER

Applicant Medical Device Technologies, Inc.

K number K974745

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DRC 1998-04-06

MANAN

Applicant Medical Device Technologies, Inc.

K number K974743

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DRC 1998-04-06

MANAN POTTS-COURNAND NEEDLE

Applicant Medical Device Technologies, Inc.

K number K974742

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DRC 1997-05-09

HEARTPORT THORACIC TROCAR

Applicant Heartport, Inc.

K number K964302

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DRC 1997-03-12

HEARTPORT NEEDLE TROCAR

Applicant Heartport, Inc.

K number K965051

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DRC 1996-03-27

GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE

Applicant Global Medical Products, Ltd.

K number K951448

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DRC 1994-05-19

MEDICON INSTRUMENTS TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES

Applicant Medicon Instruments, Inc.

K number K936247

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DRC 1994-05-12

ENDOSURG DISPOSABLE SECONDARY TROCAR

Applicant Endosurg

K number K940036

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DRC 1993-03-18

ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE

Applicant Arrow Intl., Inc.

K number K924338

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DRC 1992-06-05

R-GROUP INTL. ONE WALL PUNCTURE NEEDLE

Applicant R-Group Intl.

K number K913267

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DRC 1991-12-20

DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION

Applicant E-Z-Em, Inc.

K number K914985

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DRC 1991-07-02

LAPAROSCOPIC TROCAR

Applicant United States Endoscopy Group, Inc.

K number K911483

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DRC 1991-04-22

SURGICAL TROCAR

Applicant Applied Medical

K number K911462

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DRC 1990-07-18

DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES

Applicant Sterimed, Inc.

K number K900664

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DRC 1989-11-14

SELDINGER PERCUTANEOUS 2 PC NEEDLES

Applicant Advance Medical Designs, Inc.

K number K895455

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DRC 1989-11-14

SELDINGER SINGLE WALL; STYLE I & II (FLASHBACK)

Applicant Advance Medical Designs, Inc.

K number K895454

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DRC 1989-06-15

AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT

Applicant United States Surgical, A Division of Tyco Healthc

K number K893707

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DRC 1989-05-19

DISPOSABLE ANGIOGRAPHY NEEDLES

Applicant E-Z-Em, Inc.

K number K890209

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DRC 1987-05-07

NAMIC COURNAND STYLE INTRODUCER NEEDLE

Applicant North American Instrument Corp.

K number K871377

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DRC 1987-05-06

NAMIC ONE PART INTRODUCER NEEDLE

Applicant North American Instrument Corp.

K number K871382

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DRC 1987-05-06

NAMIC SELDINGER INTRODUCER NEEDLE

Applicant North American Instrument Corp.

K number K871378

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DRC 1986-01-15

MEDSURG POTT-COURNAND NEEDLE

Applicant Medsurg Industries, Inc.

K number K854293

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DRC 1986-01-13

MEDSURG SELDINGER NEEDLE

Applicant Medsurg Industries, Inc.

K number K854294

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DRC 1986-01-08

EMERSON TRO/CATH TROCAR CATHETERS

Applicant J. H. Emerson Co.

K number K853132

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DRC 1984-03-12

STEIGER TUNNELING INSTRUMENT 285

Applicant Evermed, Inc.

K number K840529

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DRC 1981-07-20

VISITEC NEEDLE RANGE (CARDIOVASCULAR)

Applicant Visitec Co.

K number K811964

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DRC 1978-08-23

DILUTION KIT, THERMAL, COLD PAC

Applicant Instrumentation Laboratory CO

K number K781221

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DRC 1978-01-24

NEEDLES USED IN ANGIOGRAPHIC PROCED.

Applicant Argon Medical Corp.

K number K772369

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DRC 1977-08-16

ADVANSET

Applicant C.R. Bard, Inc.

K number K771261

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