Atlas FDA

DRC

51 FDA 510(k) clearances · Product code

108 daysmedian time to decision
228 days90th percentile
51clearances measured

FDA profile

Official device name
Trocar
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1390
Medical specialty
Cardiovascular
Adverse events (MAUDE)
2021: 78 · 2022: 61 · 2023: 109 · 2024: 105 · 2025: 70 · 2026: 58
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Accusafe Transseptal Guidewire (GTR31180, GTR31230) (K240246)Synaptic Medical Corporation2024-07-26
SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) (K241042)Pressure Products Medical Device Manufacturing, LLC2024-05-17
SafeSept® Transseptal Guidewire (SS-140) (K221707)Pressure Products Medical Device Manufacturing, LLC2022-09-14
PathBuilder Transseptal Needle (K212625)Shanghai Microport EP Medtech Co., Ltd.2022-03-23
SafeSept Blunt Needle (K210328)Pressure Products Medical Device Manufacturing, LLC2021-03-05
TSN Transseptal Needle (K172950)Pressure Products Medical Device Manufacturing, LLC2018-02-21
Needle Free Transseptal Cannula (K172934)Pressure Products Medical Device Manufacturing, LLC2018-02-16
SafeSept Needle Free Transseptal Guidewire (K172893)Pressure Products Medical Device Manufacturing, LLC2017-12-21
SafeSept Transseptal Guidewire (K170671)Pressure Products Medical Device Manufacturing, LLC2017-10-20
INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE (K132943)Synaptic Medical Limited2014-08-29
SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE (K130843)Oscor, Inc.2014-01-08
BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208 (K122587)St Jude Medical2013-02-07
MOBICATH TRANSSEPTAL NEEDLE (K122832)Great Batch Medical2012-12-19
MOBICATH TRANSSEPTAL NEEDLE (K111644)Great Batch Medical2011-10-03
SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE (K081986)Oscor, Inc.2008-11-14
BRK TRANSSEPTAL NEEDLE (K072278)St Jude Medical2007-09-13
HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR (K061070)Hansen Medical, Inc.2006-10-13
MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5 (K022117)Merit Medical Systems, Inc.2002-10-11
VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX (K022257)Vomed Volzer Medizintechnik GmbH & Co.2002-10-04
TRANSSEPTAL NEEDLE/TROCAR (K011727)Thomas Medical Products, Inc.2002-05-02
INSTRUMENT DAMPING PORT (K011373)Medcanica, Inc.2001-10-12
INTERCOSTAL LOCKABLE-DIRECTABLE PORT (K011349)Medcanica, Inc.2001-10-05
MANAN (K974743)Medical Device Technologies, Inc.1998-04-06
MANAN POTTS-COURNAND NEEDLE (K974742)Medical Device Technologies, Inc.1998-04-06
MANAN GWI GUIDE WIRE INTRODUCER (K974745)Medical Device Technologies, Inc.1998-04-06
HEARTPORT THORACIC TROCAR (K964302)Heartport, Inc.1997-05-09
HEARTPORT NEEDLE TROCAR (K965051)Heartport, Inc.1997-03-12
GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE (K951448)Global Medical Products, Ltd.1996-03-27
MEDICON INSTRUMENTS TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES (K936247)Medicon Instruments, Inc.1994-05-19
ENDOSURG DISPOSABLE SECONDARY TROCAR (K940036)Endosurg1994-05-12
ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE (K924338)Arrow Intl., Inc.1993-03-18
R-GROUP INTL. ONE WALL PUNCTURE NEEDLE (K913267)R-Group Intl.1992-06-05
DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION (K914985)E-Z-Em, Inc.1991-12-20
LAPAROSCOPIC TROCAR (K911483)United States Endoscopy Group, Inc.1991-07-02
SURGICAL TROCAR (K911462)Applied Medical1991-04-22
DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES (K900664)Sterimed, Inc.1990-07-18
SELDINGER SINGLE WALL; STYLE I & II (FLASHBACK) (K895454)Advance Medical Designs, Inc.1989-11-14
SELDINGER PERCUTANEOUS 2 PC NEEDLES (K895455)Advance Medical Designs, Inc.1989-11-14
AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT (K893707)United States Surgical, A Division of Tyco Healthc1989-06-15
DISPOSABLE ANGIOGRAPHY NEEDLES (K890209)E-Z-Em, Inc.1989-05-19
NAMIC COURNAND STYLE INTRODUCER NEEDLE (K871377)North American Instrument Corp.1987-05-07
NAMIC ONE PART INTRODUCER NEEDLE (K871382)North American Instrument Corp.1987-05-06
NAMIC SELDINGER INTRODUCER NEEDLE (K871378)North American Instrument Corp.1987-05-06
MEDSURG POTT-COURNAND NEEDLE (K854293)Medsurg Industries, Inc.1986-01-15
MEDSURG SELDINGER NEEDLE (K854294)Medsurg Industries, Inc.1986-01-13
EMERSON TRO/CATH TROCAR CATHETERS (K853132)J. H. Emerson Co.1986-01-08
STEIGER TUNNELING INSTRUMENT 285 (K840529)Evermed, Inc.1984-03-12
VISITEC NEEDLE RANGE (CARDIOVASCULAR) (K811964)Visitec Co.1981-07-20
DILUTION KIT, THERMAL, COLD PAC (K781221)Instrumentation Laboratory CO1978-08-23
NEEDLES USED IN ANGIOGRAPHIC PROCED. (K772369)Argon Medical Corp.1978-01-24
ADVANSET (K771261)C.R. Bard, Inc.1977-08-16

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Every clearance here is in the API, with alerts when new ones post.