FDA.reportPublic FDA data

FUBUKI XF

Primary DI
04547327142724
Brand
FUBUKI XF
Company
ASAHI INTECC CO., LTD.
Model
FBKX-8S80DY
Published
2022-03-29
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
DQYCatheter, percutaneous
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04547327142724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04547327142724045473271427244547327142724

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French
Length80Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690711189
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04547327159517CHIKAI Nexus petitAIN-CNX-006-2202026-03-18
04547327159524CHIKAI Nexus petitAIN-CNX-006-220RC2026-03-18
04547327159531CHIKAI Nexus petitAIN-CNX-006-220J2026-03-18
04547327165563ASAHI VelouteVEL105-16SNK2026-02-05
04547327165570ASAHI VelouteVEL125-16SNK2026-02-05
04547327165587ASAHI VelouteVEL150-16SNK2026-02-05
04547327165594ASAHI Veloute C3VEL105-16SNC3K2026-02-05
04547327165600ASAHI Veloute C3VEL125-16SNC3K2026-02-05
04547327165617ASAHI Veloute C3VEL150-16SNC3K2026-02-05
04547327165624ASAHI TellusTLS105-16SNK2026-02-05
04547327165631ASAHI TellusTLS125-16SNK2026-02-05
04547327165648ASAHI TellusTLS150-16SNK2026-02-05
04547327165655ASAHI Tellus C3TLS105-16SNC3K2026-02-05
04547327165662ASAHI Tellus C3TLS125-16SNC3K2026-02-05
04547327165679ASAHI Tellus C3TLS150-16SNC3K2026-02-05
04547327163361CROSSLEAD Pro 018CPR01810S2025-12-15
04547327163378CROSSLEAD Pro 018CPR01810P2025-12-15
04547327163385CROSSLEAD Pro 018CPR01820S2025-12-15
04547327163392CROSSLEAD Pro 018CPR01820P2025-12-15
04547327163408CROSSLEAD Pro 018CPR01823S2025-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810024671953SSPC NXT Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-06-01
08718481740330Guidion ShortIMDS Operations B.V.DQY2026-06-01
08718481740347FlowGuideIMDS Operations B.V.DQY2026-06-01
07613327623338AXS LiftStryker CorporationDQY2025-03-04
07613327623352AXS LiftStryker CorporationQJP2025-03-04
07613327623376AXS LiftStryker CorporationDQY2025-03-04
07613327623390AXS LiftStryker CorporationQJP2025-03-04
00842429106563Balloon CatheterMicrovention, Inc.DQY2022-06-14
00763000539351RebarMicro Therapeutics, Inc.QJP2022-02-27
07613327519372AXS VECTA 46Stryker CorporationQJP2021-12-17
07613327313956Trevo Trak 21Stryker CorporationQJP2020-04-17
00763000270346Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270353Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270360Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270377Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270384Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270520Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270537Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270544Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270551Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270704Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270711Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270766Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270773Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270216Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270223Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270230Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270247Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270254Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270292Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07