FDA.reportPublic FDA data

VASSALLO GT EXT

Primary DI
14582105830117
Brand
VASSALLO GT EXT
Company
FILMEC K.K.
Model
VGT14165EXT
Catalog number
VGT14165EXT
Published
2023-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQXWire, Guide, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222631000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222631000VASSALLO GT EXTFilmecc Co., Ltd.2022-10-26DQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14582105830117PackageGS15In Commercial Distribution
04582105830110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1458210583011714582105830117
04582105830110045821058301104582105830110

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular guidewire, manualA long, thin wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length165Centimeter
Outer Diameter0.014Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
718142096
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04582105830141VASSALLO GT Crossing12VGT18190G12VGT18190G122023-11-30
04582105830158VASSALLO GT Crossing30VGT18190G30VGT18190G302023-11-30
04582105830165VASSALLO GT Crossing12VGT18300G12VGT18300G122023-11-30
04582105830172VASSALLO GT Crossing30VGT18300G30VGT18300G302023-11-30
04582105830035VASSALLO GT Crossing14VGT14190G14VGT14190G142023-11-30
04582105830059VASSALLO GT Crossing14VGT14300G14VGT14300G142023-11-30
14582105830148VASSALLO GT Crossing12VGT18190G12VGT18190G122023-11-30
14582105830155VASSALLO GT Crossing30VGT18190G30VGT18190G302023-11-30
14582105830162VASSALLO GT Crossing12VGT18300G12VGT18300G122023-11-30
14582105830179VASSALLO GT Crossing30VGT18300G30VGT18300G302023-11-30
04582105830196VASSALLO GT 018 HybridVGT18300HYBVGT18300HYB2023-06-02
04582105830189VASSALLO GT 018 HybridVGT18190HYBVGT18190HYB2023-06-02
14582105830193VASSALLO GT 018 HybridVGT18300HYBVGT18300HYB2023-06-02
04582105830110VASSALLO GT EXTVGT14165EXTVGT14165EXT2023-05-18
04582105830127VASSALLO GT 018 FloppyVGT18190FLPVGT18190FLP2023-02-10
14582105830124VASSALLO GT 018 FloppyVGT18190FLPVGT18190FLP2023-02-10
04582105830134VASSALLO GT 018 FloppyVGT18300FLPVGT18300FLP2023-02-10
04582105830042VASSALLO GT CrossingVGT14190G40VGT14190G402023-01-26
04582105830066VASSALLO GT CrossingVGT14300G40VGT14300G402023-01-26
04582105830073VASSALLO GT SupportVGT14190XSPVGT14190XSP2023-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260461060036EMERYGLIDENano4Imaging GmbHDQX2026-07-23
07290015107426Drivewire 35 GuidewireRAPID MEDICAL LTDDQX2026-07-20
06936733736951ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-07-10
00884450529348SplashWire™Merit Medical Systems, Inc.DQX2026-07-07
06947358524021Sunmed™ guide wiresSunny Medical Device (Shenzhen) Co., Ltd.DQX2026-07-07
06947358535454Sunmed™ guide wiresSunny Medical Device (Shenzhen) Co., Ltd.DQX2026-07-07
06971428595857DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595864DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595871DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595888DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595895DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595901DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595918DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595925DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
00816349014994CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015007CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015014CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015021CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015038CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015045CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015052CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015069CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015076CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015083CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349012570Safari2Lake Region MedicalDQX2026-06-25
00816349012587Safari2Lake Region MedicalDQX2026-06-25
00816349012594Safari2Lake Region MedicalDQX2026-06-25
00816349013676WallStentLake Region MedicalDQX2026-06-25
00884450589977SplashWire™Merit Medical Systems, Inc.DQX2026-06-02
07649989542021SmartGUIDE deflectable hydrophilic guidewire Artiria Medical SADQX2026-03-02