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FuStarTM Steerable introducer

FDA UDI

Class II (US FDA UDI)

by Lifetech Scientific (Shenzhen) Co., Ltd.

Identity

Trade Name
FuStarTM Steerable introducer FDA UDI
Generic Name
Cardiac occluder delivery kit FDA UDI
Device Name
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
SLA6F-900 FDA 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
06938370117094 FDA UDI
510(k) Number
K100184 FDA UDI
FDA Product Code
DQY FDA UDI
GMDN Term
Cardiac occluder delivery kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiac occluder delivery kit

FuStarTM Steerable introducer by Lifetech Scientific (Shenzhen) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac occluder delivery kit.

Cleared under the same submission

K100184 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lifetech Scientific (Shenzhen) Co., Ltd.

Sources (1)

  • FDA UDI f3149507-b3e1-400e-82b9-931b6816dcb3 34 fields · synced May 30, 2026