FDA.reportPublic FDA data

VASSALLO GT Crossing12

Primary DI
04582105830141
Brand
VASSALLO GT Crossing12
Company
FILMEC K.K.
Model
VGT18190G12
Catalog number
VGT18190G12
Published
2023-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K232578000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232578000VASSALLO GT 018 G12; VASSALLO GT 018 G30Filmec Co. , Ltd.2023-10-11DQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14582105830148PackageGS15In Commercial Distribution
04582105830141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1458210583014814582105830148
04582105830141045821058301414582105830141

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
Length190Centimeter
Outer Diameter0.018Inch

Regulatory Flags#

DUNS number
718142096
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
14582105830117VASSALLO 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
00884450589977SplashWire™Merit Medical Systems, Inc.DQX2026-06-02
07649989542021SmartGUIDE deflectable hydrophilic guidewire Artiria Medical SADQX2026-03-02
07640142811305Guidewire 0.025 6/270cm angled Straub Medical AGDQX2022-06-30
07640142811312SET Aspirex™ S 6F 110cmStraub Medical AGDQX2022-06-30
07640142811329SET Aspirex™ S 6F 135cmStraub Medical AGDQX2022-06-30
07640142811336SET Aspirex™ S 8F 85cmStraub Medical AGDQX2022-06-30
07640142811343SET Aspirex™ S 8F 110cmStraub Medical AGDQX2022-06-30
07640142811350SET Aspirex™ S 10F 110cmStraub Medical AGDQX2022-06-30
07640142811855SET Rotarex™S 6 F x 110 cmStraub Medical AGDQX2022-05-04
07640142811862SET Rotarex™S 6 F x 135 cm Straub Medical AGDQX2022-05-04
07640142811879SET Rotarex™S 8 F x 85 cm Straub Medical AGDQX2022-05-04
07640142811886SET Rotarex™S 8 F x 110 cmStraub Medical AGDQX2022-05-04
10193489078022NAMICMEDLINE INDUSTRIES, INC.DQX2022-02-24
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07640142810575SET Rotarex®S 6F 110cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07640142810582SET Rotarex®S 6F 135cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07640142810599SET Rotarex®S 8F 85cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07640142810605SET Rotarex®S 8F 110 cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07613327459647Synchro2Stryker CorporationDQX2019-06-20
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