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
Oct 15, 2026K262674Giranel Guiding Sheath Set
Kossel Medtech (Suzhou) Co., Ltd., CN
DYB
Jul 29, 2026K253526NAMIC Dilator and Sheath
Medline Industries, LP
DYB
Jul 6, 2026K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (
Hartman Medical Group, LLC
DYB
Jun 25, 2026K261242SimplGuide
Pendracare, NL
DYB
Jun 22, 2026K261950Health Line Tearaway Introducer
Health Line International Corporation
DYB
Jun 5, 2026K261492FieldFlex Steerable Sheath
CenterPoint Systems, LLC
DYB
Apr 29, 2026K260606Echo Large Bore Introducer Sheath
Echo Medical, LLC
DYB
Apr 23, 2026K254248Introducer Sheath Set
Cardiocycle Medical(Suzhou) Co., Ltd., CN
DYB
Apr 17, 2026K254279Edwards eSheath+ introducer set
Edwards Lifesciences
DYB
Apr 13, 2026K260091Aventus Introducer Sheath
Inquis Medical
DYB
Apr 10, 2026K260839Protaryx Transseptal Puncture Device (PTX2-001)
Protaryx Medical, Inc.
DYB
Apr 7, 2026K260942AuST Steerable Sheath
CenterPoint Systems, LLC
DYB
Apr 6, 2026K260459VANES Delivery System (VDS)
Zoll Respicardia, Inc.
DYB
Mar 26, 2026K260626Multiflex Steerable Sheath 17.5F
Vizaramed, Inc.
DYB
Feb 19, 2026K260163AuST CSP Introducer
CenterPoint Systems, LLC
DYB
Feb 9, 2026K254236Peel-Away Introducer Sheath
VascuTech Medical, LLC
DYB
Jan 22, 2026K253652Genie MAX Large Bore Introducer Sheath
Cultiv8 1, LLC
DYB
Dec 17, 2025K252508Intri26 Introducer Sheath
Inari Medical, Inc.
DYB
Dec 15, 2025K253741V•Stick™ Vascular Access Set
Argon Medical Devices, Inc.
DYB
Oct 23, 2025K252309PerQseal Introducers
Vivasure Medical Limited, IE
DYB
Oct 21, 2025K251838Introducer Sheath Set
Cardiocycle Medical(Suzhou) Co., Ltd., CN
DYB
Oct 8, 2025K25276614Fr Low Profile Introducer Kit
Abiomed, Inc.
DYB
Sep 29, 2025K252441Primero Safe Access System
South53, LLC
DYB
Sep 24, 2025K252227Pounce(TM) Sheath
Surmodics,Inc.
DYB
Sep 12, 2025K252027Vertex(TM) Catheter
Jupiter Endovascular
DYB
Aug 29, 2025K252364Edwards eSheath Optima introducer set
Edwards Lifesciences
DYB
Apr 30, 2025K251051AuST Steerable Sheath
CenterPoint Systems, LLC
DYB
Apr 25, 2025K250909Prelude Wave Hydrophilic Sheath Introducer
Merit Medical Systems, Inc.
DYB
Apr 24, 2025K243954PeriCross™ Epicardial Access Kit
Circa Scientific, Inc.
DYB
Mar 27, 2025K244046Edwards eSheath Optima introducer set
Edwards Lifesciences
DYB
Mar 20, 2025K250468iSLEEVE Introducer Set
Boston Scientific
DYB
Mar 20, 2025K243928ViaOne Epicardial Access System
Cardiovia , Ltd., IL
DYB
Mar 16, 2025K250439Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide She
Contract Medical International, GmbH, DE
DYB
Dec 13, 2024K243493Agilis NxT Steerable Introducer Dual-Reach
ABBOTT MEDICAL
DYB
Nov 20, 2024K242520Element Vascular Access System
Penumbra, Inc.
DYB
Nov 8, 2024K242756Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFl
Pulnovo Medical (Wuxi) Co., Ltd., CN
DYB
Nov 4, 2024K243061SonoStik Guide Wire Introducer
Sonostik, LLC
DYB
Oct 4, 2024K242106AuST Steerable Sheath
CenterPoint Systems, LLC
DYB
Sep 17, 2024K241230Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008
Togo Medikit Co., Ltd., JP
DYB
Sep 6, 2024K240600SafeCross Vascular Introducer System (4001)
East End Medical I, LLC
DYB
Aug 23, 2024K242169Morph DNA Steerable Introducer Sheath
Biocardia
DYB
Aug 22, 2024K242248Introducer Sheath Kits
Beijing Demax Medical Technology Co.,Ltd, CN
DYB
Aug 14, 2024K240957Catapult Guide Sheath
Contract Medical International, GmbH, DE
DYB
Aug 6, 2024K241708Abiomed 14Fr Low Profile Introducer Kit
Abiomed, Inc.
DYB
Aug 1, 2024K241145TLAB® Transvenous Liver Biopsy System (TF-18C)
Argon Medical Devices, Inc.
DYB
Jun 13, 2024K241370Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED)
ABBOTT MEDICAL
DYB
May 1, 2024K240829AuST Steerable Sheath
CenterPoint Systems, LLC
DYB
Mar 25, 2024K240589Micropuncture Introducer Sets; Micropuncture Pedal Access Sets
Cook Medical
DYB
Feb 16, 2024K233708NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)
Synaptic Medical Corporation
DYB
Feb 13, 2024K233959EPi-Ease Epicardial Access Device (EAS)
AtriCure, Inc.
DYB

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