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)
Top companies in DRE
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2026 | Argon Medical Devices, Inc One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular Open, Classified |
DRE | K780126 |
| May 7, 2025 | Galt 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 |
DRE | K000737 |
| Sep 20, 2024 | Merit Medical Systems, Inc. Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F) Open, Classified |
DRE | K070159 |
| Mar 21, 2024 | Angiodynamics, 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 |
DRE | K132713 |
| Mar 21, 2024 | Angiodynamics, 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 |
DRE | K132713 |
| Mar 21, 2024 | Angiodynamics, 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 |
DRE | K132713 |
| Mar 21, 2024 | Angiodynamics, 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 |
DRE | K132713 |
| Mar 21, 2024 | Angiodynamics, 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 |
DRE | K132713 |
| Mar 21, 2024 | Angiodynamics, 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 |
DRE | K132713 |
| Mar 21, 2024 | Angiodynamics, 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 |
DRE | K132713 |
| Mar 21, 2024 | Angiodynamics, 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 |
DRE | K132713 |
| Mar 21, 2024 | Angiodynamics, 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 |
DRE | K132713 |
| Mar 21, 2024 | Angiodynamics, Inc. MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG
Catalog Number: 45-756 Open, Classified |
DRE | K132713 |
| Mar 21, 2024 | Angiodynamics, 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 |
DRE | K132713 |
| Mar 21, 2024 | Angiodynamics, 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 |
DRE | K132713 |
| Mar 21, 2024 | Angiodynamics, 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 |
DRE | K132713 |
| Mar 21, 2024 | Angiodynamics, 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 |
DRE | K132713 |
| Mar 21, 2024 | Angiodynamics, 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 |
DRE | K132713 |
| Jun 9, 2021 | Cordis Corporation Avanti+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices. Terminated |
DRE | K970392 |
| Mar 19, 2021 | Cardiac 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 |
DRE | K162181 |
| Jun 19, 2020 | Argon 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 |
DRE | K780126 |
| Feb 20, 2020 | Maquet Cardiovascular Us Sales, Llc Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039 Terminated |
DRE | K081940 |
| May 2, 2018 | Galt 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 |
DRE | K000737 K172487 |
| Mar 15, 2016 | Cordis 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 |
DRE | K970392 |
| Mar 1, 2016 | Argon 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 |
DRE | K780126 |
| Dec 1, 2015 | Procedure 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 |
DRE | K810859 |
| Jun 22, 2015 | Merit 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 |
DRE | K070159 |
| Nov 21, 2011 | Boston 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 |
DRE | K052557 |
| Jun 2, 2010 | Argon 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 |
DRE | K781333 |
| May 11, 2010 | Galt Medical Corp Micro Introducer Kit 5F, Model number: KIT-014-29, & Customer Model number: 7204. Vascular Solutions, 6464 Sycamore Court, Minneapolis, MN 53369. Terminated |
DRE | K000737 |
| Feb 2, 2010 | Argon 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 |
DRE | K780126 |
| Dec 14, 2009 | Merit 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 |
DRE | K050962 |
| Aug 4, 2004 | Merit Medical Systems, Inc Merit MAK Mini Access Kit, 4 French (1.3mm) Terminated |
DRE | K031691 |
| Aug 4, 2004 | Merit Medical Systems, Inc Merit MAK Mini Access Kit, 4 French (1.3mm) Terminated |
DRE | K031691 |
| Aug 4, 2004 | Merit Medical Systems, Inc Merit MAK Mini Access Kit, 4 French (1.3mm) Terminated |
DRE | K031691 |
| Jul 20, 2004 | Boston 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 |
DRE | None listed |
| Jul 20, 2004 | Boston 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 |
DRE | None listed |
| Jul 20, 2004 | Boston 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 |
DRE | None listed |
| Jul 20, 2004 | Boston 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 |
DRE | None listed |
| Jul 20, 2004 | Boston 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 |
DRE | K974640 |
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