ClearanceBrief
Panels › Cardiovascular › Product code DRE · Class 2

Dilator, Vessel, For Percutaneous Catheterization

Regulation 870.1310

2510(k)s in 12 months (105 all time)
1recalls in 12 months (40 all time)
36recalls that name a 510(k)
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Top companies in DRE

DateFirm and productCodeLinked 510(k)
Jul 10, 2026Argon Medical Devices, Inc
One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
Open, Classified
DREK780126
May 7, 2025Galt Medical Corporation
B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the vascu
Open, Classified
DREK000737
Sep 20, 2024Merit Medical Systems, Inc.
Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
Open, Classified
DREK070159
Mar 21, 2024Angiodynamics, Inc.
MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. - Catalog Number: 45-781
Open, Classified
DREK132713
Mar 21, 2024Angiodynamics, Inc.
MINI STICK MAX 5F X 15 CM STIFF .018 NI/TU NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-776
Open, Classified
DREK132713
Mar 21, 2024Angiodynamics, Inc.
MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-775
Open, Classified
DREK132713
Mar 21, 2024Angiodynamics, Inc.
MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-774
Open, Classified
DREK132713
Mar 21, 2024Angiodynamics, Inc.
MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-767
Open, Classified
DREK132713
Mar 21, 2024Angiodynamics, Inc.
MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-765
Open, Classified
DREK132713
Mar 21, 2024Angiodynamics, Inc.
MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-762
Open, Classified
DREK132713
Mar 21, 2024Angiodynamics, Inc.
MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-759
Open, Classified
DREK132713
Mar 21, 2024Angiodynamics, Inc.
MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-758
Open, Classified
DREK132713
Mar 21, 2024Angiodynamics, Inc.
MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756
Open, Classified
DREK132713
Mar 21, 2024Angiodynamics, Inc.
MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-754
Open, Classified
DREK132713
Mar 21, 2024Angiodynamics, Inc.
MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-752
Open, Classified
DREK132713
Mar 21, 2024Angiodynamics, Inc.
MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-751
Open, Classified
DREK132713
Mar 21, 2024Angiodynamics, Inc.
MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-750
Open, Classified
DREK132713
Mar 21, 2024Angiodynamics, Inc.
MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-749
Open, Classified
DREK132713
Jun 9, 2021Cordis Corporation
Avanti+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
Terminated
DREK970392
Mar 19, 2021Cardiac Assist, Inc
Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17 Catalog #: 5840-2415 - LS Tandem Life Kit - V24/A15 Catalog #: 5
Terminated
DREK162181
Jun 19, 2020Argon Medical Devices, Inc
ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or convenience kits bui
Terminated
DREK780126
Feb 20, 2020Maquet Cardiovascular Us Sales, Llc
Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
Terminated
DREK081940
May 2, 2018Galt Medical Corporation
1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11; 2) Enhance Transcarotid/Peripheral Access Kit, Sterile EO, Rx Only, Catalog #: a) KIT-075-02;
Terminated
DREK000737
K172487
Mar 15, 2016Cordis Corporation
CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intra
Terminated
DREK970392
Mar 1, 2016Argon Medical Devices, Inc
ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11. Indicated for use in arterial and venous procedures r
Terminated
DREK780126
Dec 1, 2015Procedure Products, Inc.
U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for further processing. Needles are packaged in zipper-bags, 300 pieces per bag, wi
Terminated
DREK810859
Jun 22, 2015Merit Medical Systems, Inc.
Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduct
Terminated
DREK070159
Nov 21, 2011Boston Scientific Corporation
Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths, Sterile EO, Manufactured by Togo Medikit Co., Ltd. 17148-6 Aza Kamekawa, Oaza Hichiya, Hyuga City, Miyazaki Prefecture 883-0062
Terminated
DREK052557
Jun 2, 2010Argon Medical Devices, Inc
CATHETER INTRODUCER KIT PCI KIT/5 REF/REORDER NO. 496185. Disposable Single Use, Rx.. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.
Terminated
DREK781333
May 11, 2010Galt Medical Corp
Micro Introducer Kit 5F, Model number: KIT-014-29, & Customer Model number: 7204. Vascular Solutions, 6464 Sycamore Court, Minneapolis, MN 53369.
Terminated
DREK000737
Feb 2, 2010Argon Medical Devices, Inc
Percutaneous Catheter Introducer Set, VNUS Medical Technologies Cath Shth Intro 7F x 7cm, catalog number IS-7F07, Disposable, Single Use, Do Not Re-sterilize, Manufactured in USA for VNUS, 5799 Fontan
Terminated
DREK780126
Dec 14, 2009Merit Medical Systems, Inc.
Merit Medical Systems, Inc. Prelude Pro Sheath Introducer REF/CAT No.: PRO-6F-11-035 Prelude PRO SHEATH INTRODUCER 6F 11 cm to provide access and facilitate the percutaneous introduction of various
Terminated
DREK050962
Aug 4, 2004Merit Medical Systems, Inc
Merit MAK Mini Access Kit, 4 French (1.3mm)
Terminated
DREK031691
Aug 4, 2004Merit Medical Systems, Inc
Merit MAK Mini Access Kit, 4 French (1.3mm)
Terminated
DREK031691
Aug 4, 2004Merit Medical Systems, Inc
Merit MAK Mini Access Kit, 4 French (1.3mm)
Terminated
DREK031691
Jul 20, 2004Boston Scientific Corp
Boston Scientific/MEDI-TECH brand Fascial Dilator, 10 FR (3.3 mm), sterile, single use only, model M001482501, REF/Catalog No. 48-250.
Terminated
DRENone listed
Jul 20, 2004Boston Scientific Corp
Boston Scientific/MEDI-TECH brand Fascial Dilator, 8 FR(2.7 mm), sterile, single use only, model M001481541; Catalog No. 48-154.
Terminated
DRENone listed
Jul 20, 2004Boston Scientific Corp
Product in clear plastic pouch labeled: Boston Scientific MEDI-TECH *** VASCULAR DILATOR *** Order No./REF: 48-151 M001481510, 5 Fr. Firm on the label: Boston Scientific Corporation, 480 Pleasant Str
Terminated
DRENone listed
Jul 20, 2004Boston Scientific Corporation
VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (5 Fr), a 21 Ga. echogenic entry needle, and a .018 in. / 0,46 mm guidewire with a floppy lip. Cat. #45-994. Fi
Terminated
DRENone listed
Jul 20, 2004Boston Scientific Corporation
VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (4 Fr), a 21 Ga. echogenic entry needle, and a .018 in. / 0,46 mm guidewire with a floppy lip. Cat. #45-988. Fi
Terminated
DREK974640

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