Fustar

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref SVA5F-700

by Lifetech Scientific (Shenzhen) Co., Ltd.

Identity

Trade Name: Fustar EUDAMED
FuStarTM Steerable introducer FDA UDI
Generic Name: Cardiac occluder delivery kit FDA UDI
Device Name: Fustar™ Steerable Introducer EUDAMED
The FuStarTM Steerable Introducers are designed to perform as a guiding shealth and/or introducer sheath, which provides a pathway through whichdevices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature. Its low- profile design and atraumatic tip reduce the potential risk for trauma during percutaneous punctures while facilitating passage of a wide variety of cathelters and devices. The proposed introducer can give physicians good control during operation, the curl options are available at 30mm (Small) and 50mm(Large). Ineach option, there are 2 connector types which are luer lock connector and silicone valve connector, and several specifications combination Also, the visible knob with scale of controller facillitates the physicians to estimate the deflecting angle of the sheath while intra-operation. The products are available in different effective length (550mm, 700mm and 900mm) and diameter (French sie, 5F, 6F, 7F, 8F, 9F and 10F). The deflection angle of shealth is from 0 degree to 180 degree. FDA UDI
Model / Reference: SVA5F-700 EUDAMEDFDA UDI
Description: The FuStarTM Steerable Introducers are designed to perform as a guiding shealth and/or introducer sheath, which provides a pathway through whichdevices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature. Its low- profile design and atraumatic tip reduce the potential risk for trauma during percutaneous punctures while facilitating passage of a wide variety of cathelters and devices. The proposed introducer can give physicians good control during operation, the curl options are available at 30mm (Small) and 50mm(Large). Ineach option, there are 2 connector types which are luer lock connector and silicone valve connector, and several specifications combination Also, the visible knob with scale of controller facillitates the physicians to estimate the deflecting angle of the sheath while intra-operation. The products are available in different effective length (550mm, 700mm and 900mm) and diameter (French sie, 5F, 6F, 7F, 8F, 9F and 10F). The deflection angle of shealth is from 0 degree to 180 degree. FDA UDI

Identifiers

Primary DI / UDI-DI: 06938370116233 EUDAMED
06938370117292 FDA UDI
Basic UDI-DI: B-06938370116233 EUDAMED
510(k) Number: K100184 FDA UDI
FDA Product Code: DQY FDA UDI
EMDN Code: P0780 VASCULAR AND CARDIAC PROSTHESES - ACCESSORIES EUDAMED
GMDN Term: Cardiac occluder delivery kit FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 870.1250 FDA UDI
Market of Registration: France EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Fustar by Lifetech Scientific (Shenzhen) Co., Ltd. — Class IIa — CE/MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-06938370116233	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: Lifetech Scientific (Shenzhen) Co., Ltd.
EUDAMED SRN: CN-MF-000001561
Authorised Representative: LifeTech Scientific (Europe) B.V. NL-AR-000000804

Sources (2)

EUDAMED 4b8aff2a-3636-411c-860e-feafb5ce4671 61 fields · synced Jun 1, 2026
FDA UDI 8dad564a-c447-423e-b152-7d7146937751 34 fields · synced May 25, 2026