ClearanceBrief
Panels › Cardiovascular › Product code DYB · Class 2

Introducer, Catheter

Regulation 870.1340

19510(k)s in 12 months (707 all time)
27recalls in 12 months (389 all time)
337recalls that name a 510(k)
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Top companies in DYB

Company510(k)sRecalls
Cook Incorporated2067
Terumo Medical Corp.2729
Merit Medical Systems1935
Oscor, Inc.1337
ARROW INTERNATIONAL, LLC037
Abiomed, Inc.628
Thomas Medical Products, Inc.1715
St Jude Medical263
Cordis Corp.223
Boston Scientific166
Decided510(k)Device and applicantCode
Jan 31, 2024K240004CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); C
Circa Scientific, Inc.
DYB
Dec 20, 2023K231227SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath
Baylis Medical Company, Inc., CA
DYB
Dec 17, 2023K233691FlexCath Cross Transseptal Solution
Acutus Medical, Inc.
DYB
Dec 12, 2023K233646Intri24 Introducer Sheath (52-101)
Inari Medical, Inc.
DYB
Dec 8, 2023K23343210F Sheath and Dilator Set
Argon Medical Devices, Inc.
DYB
Nov 30, 2023K23350314F iSLEEVE Introducer Set
Boston Scientific Corporation
DYB
Sep 27, 2023K232260Thinline Sheath Introducer
Inneuroco, Inc.
DYB
Sep 27, 2023K231108Talon Transseptal Sheath
Inari Medical, Inc.
DYB
Sep 7, 2023K231828Pounce™ Sheath
Surmodics,Inc.
DYB
Jul 10, 2023K231412CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)
Biosense Webster, Inc.
DYB
May 22, 2023K230631Kodiak™ Dual Port Coaxial Introducer Kit
Argon Medical Devices
DYB
Apr 24, 2023K230704RAIN Sheath™ Tibial Pedal Introducer
Cordis US Corp
DYB
Mar 1, 2023K230283Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 40
ABBOTT MEDICAL
DYB
Feb 21, 2023K222184Introducer Sheath Kits
Beijing Demax Medical Technology Co.,Ltd, CN
DYB
Feb 3, 2023K23005114F iSLEEVE™ Introducer Set
Boston Scientific Corporation
DYB
Jan 19, 2023K223872Low Profile Companion Sheath
Merit Medical Systems, Inc.
DYB
Nov 14, 2022K221655Multiflex Steerable Sheath
Vizaramed, Inc.
DYB
Oct 13, 2022K222113Abiomed 14Fr Low Profile Introducer Set
Abiomed, Inc.
DYB
Jul 29, 2022K221914Catapult Guide Sheath
Contract Medical International, GmbH, DE
DYB
Jun 30, 2022K213582Epicardial Access System
Baylis Medical Company, Inc., CA
DYB
May 31, 2022K221440Liverty™ TIPS Access Set
Bard Peripheral Vascular, Inc.
DYB
May 9, 2022K220414VersaCross Connect Transseptal Dilator
Baylis Medical Company, Inc., CA
DYB
Apr 27, 2022K220604EXTesia Introducer Sheath Set
Curatia Medical Co.
DYB
Apr 1, 2022K212392Intri24 Sheath
Inari Medical, Inc.
DYB
Mar 24, 2022K213492Dib UltraNav Transseptal Catheter System
Dib Ultranav Medical, LLC
DYB
Mar 23, 2022K212626PathBuilder Transseptal Guiding Introducer
Shanghai Microport EP Medtech Co., Ltd., CN
DYB
Feb 8, 2022K220047AcQCross Qx Integrated Transseptal Dilator/Needle
Acutus Medical, Inc.
DYB
Feb 8, 2022K211530PathBuilder Steerable Introducer
Shanghai Microport EP Medtech Co., Ltd., CN
DYB
Jan 7, 2022K212152Prelude IDeal 9F Hydrophilic Sheath Introducer
Merit Medical Systems
DYB
Dec 10, 2021K213638Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga N
Argon Medical Devices
DYB
Oct 14, 2021K213002SCORPION Portal Vein Access Set
Argon Medical Devices
DYB
Oct 4, 2021K211405Prelude Guide Sheath
Merit Medical Systems, Inc.
DYB
Sep 23, 2021K212708Halo One Thin-Walled Guiding Sheath
C.R. Bard, Inc., IE
DYB
Jul 27, 2021K211989Aveir Introducer
ABBOTT MEDICAL
DYB
Jul 23, 2021K210185CardioCurve Steerable Sheath
Talon Surgical
DYB
Jul 6, 2021K203459SafeCross Transseptal Puncture and Introducer (TSP/I) System
East End Medical I, LLC
DYB
Jun 3, 2021K210627Breezeway II
Oscor, Inc.
DYB
Apr 6, 2021K210685AcQCross Qx Integrated Transseptal Dilator/Needle
Acutus Medical, Inc.
DYB
Feb 26, 2021K202167Brite Tip Radianz Guiding Sheath
Cordis Corporation
DYB
Feb 16, 2021K203670Extra Large Check-Flo Introducer
Cook Incorporated
DYB
Jan 15, 2021K202141Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set
Argon Medical Devices, Inc.
DYB
Dec 22, 2020K201489Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Po
Argon Medical Devices, Inc.
DYB
Dec 15, 2020K202226Lim Precision Steerable TS, Steerable Sheath, Dilator
Keystone Heart, Ltd., IL
DYB
Dec 7, 2020K202330Impella XR Sheath Set
Abiomed, Inc.
DYB
Nov 20, 2020K203179Fortress Introducer Sheath System
Contract Medical International, GmbH, DE
DYB
Oct 6, 2020K202584iSleeve Introducer Set
Boston Scientific Corporation
DYB
Jun 15, 2020K201116Abiomed 23 Fr Sheath
Abiomed, Inc.
DYB
Mar 9, 2020K200258Edwards eSheath Introducer Set
Edwards Lifesciences
DYB
Jan 17, 2020K193509AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX
Acutus Medical, Inc.
DYB
Jan 6, 2020K193125R2P Destination Slender Guiding Sheath
Terumo Medical Corporation
DYB

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