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Fustar
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SVB9F-800Ref SVB7F-800Ref SVB10F-800Ref SVB6F-800Ref SVA10F-800Ref SVA14F-900Ref SVB12F-550Ref SVB5F-800Ref SVA6F-800Ref SVA5F-800Ref SVB14F-800Ref SVB14F-700Ref SVB12F-800Ref SVA9F-800Ref SVB9F-550Ref SVB6F-550Ref SVB14F-550Ref SVB12F-900Ref SVB8F-800Ref SVB6F-900Ref SVA6F-900Ref SVB10F-900Ref SVA9F-900
Identity
- Trade Name
- Fustar EUDAMEDFuStarTM Steerable introducer FDA UDI
- Generic Name
- Cardiac occluder delivery kit FDA UDI
- Device Name
- Fustar™ Steerable Introducer EUDAMED06938370119593 EUDAMED06938370119586 EUDAMEDThe 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
- SVB9F-800 EUDAMEDSVB7F-800 EUDAMEDSVB10F-800 EUDAMEDSVB6F-800 EUDAMEDSVA10F-800 EUDAMEDSVA14F-900 EUDAMEDSVB12F-550 EUDAMEDSVB5F-800 EUDAMEDSVA6F-800 EUDAMEDSVA5F-800 EUDAMEDSVB14F-800 EUDAMEDSVB14F-700 EUDAMEDSVB12F-800 EUDAMEDSVA9F-800 EUDAMEDSVB10F-900 EUDAMEDFDA UDISVB6F-550 EUDAMEDFDA UDISVA6F-900 EUDAMEDFDA UDISVB9F-550 EUDAMEDFDA UDISVB6F-900 EUDAMEDFDA UDISVA9F-900 EUDAMEDFDA UDISVB14F-550 EUDAMEDSVB12F-900 EUDAMEDSVB8F-800 EUDAMED
- 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
- 06938370119722 EUDAMED06938370119708 EUDAMED06938370119739 EUDAMED06938370119692 EUDAMED06938370119593 EUDAMED06938370116912 EUDAMED06938370116981 EUDAMED06938370119685 EUDAMED06938370119555 EUDAMED06938370119548 EUDAMED06938370119753 EUDAMED06938370117025 EUDAMED06938370119746 EUDAMED06938370119586 EUDAMED06938370116769 EUDAMED06938370116677 EUDAMED06938370117018 EUDAMED06938370117001 EUDAMED06938370119715 EUDAMED06938370116691 EUDAMED06938370116271 EUDAMED06938370116813 EUDAMED06938370116363 EUDAMED06938370117933 FDA UDI06938370117797 FDA UDI06938370117339 FDA UDI06938370117889 FDA UDI06938370117810 FDA UDI06938370117421 FDA UDI
- Basic UDI-DI
- B-06938370119722 EUDAMEDB-06938370119708 EUDAMEDB-06938370119739 EUDAMEDB-06938370119692 EUDAMEDB-06938370119593 EUDAMEDB-06938370116912 EUDAMEDB-06938370116981 EUDAMEDB-06938370119685 EUDAMEDB-06938370119555 EUDAMEDB-06938370119548 EUDAMEDB-06938370119753 EUDAMEDB-06938370117025 EUDAMEDB-06938370119746 EUDAMEDB-06938370119586 EUDAMEDB-06938370116769 EUDAMEDB-06938370116677 EUDAMEDB-06938370117018 EUDAMEDB-06938370117001 EUDAMEDB-06938370119715 EUDAMEDB-06938370116691 EUDAMEDB-06938370116271 EUDAMEDB-06938370116813 EUDAMEDB-06938370116363 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 EUDAMEDClass 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
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Fustar by Lifetech Scientific (Shenzhen) Co., Ltd. — Class IIa — MDD, 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-06938370119722 | 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 (29)
- EUDAMED f6131c61-5136-46e4-8b00-fb411eb34df6 61 fields · synced Oct 6, 2026
- EUDAMED 173f4b12-acf8-4e2f-bef3-3083338ef7d3 61 fields · synced May 11, 2026
- EUDAMED 82069815-e6e4-47b7-89b4-9f5dc0639881 61 fields · synced May 16, 2026
- EUDAMED a0d08c6c-9c20-4867-bede-cd52035e7fb3 61 fields · synced May 16, 2026
- EUDAMED 1cb8b711-57ca-40c1-b404-a7cb616a770a 61 fields · synced May 17, 2026
- EUDAMED 316707bf-274e-4403-9c6c-5c52b63fccf6 61 fields · synced May 17, 2026
- EUDAMED 722fc6c8-73a9-409c-943a-637a7cfaf864 61 fields · synced May 17, 2026
- EUDAMED db74d15c-09c8-4abe-8227-1624dab0676a 61 fields · synced May 17, 2026
- EUDAMED de90ab24-0408-44be-bb6a-da33d7ac92f0 61 fields · synced May 17, 2026
- EUDAMED 2b58b1b9-4196-4022-b28c-c5629984f4d6 61 fields · synced May 18, 2026
- EUDAMED 48a083b7-720c-4df8-a3e7-c26a301f52c1 61 fields · synced May 18, 2026
- EUDAMED 0cfc26a0-a813-41f7-825f-ab16c177f397 61 fields · synced May 18, 2026
- EUDAMED 3e8d5091-2e43-4d60-b3f7-f6956f61227f 61 fields · synced May 18, 2026
- EUDAMED 6b5efe09-66bb-4175-aba7-c32f5b79b119 61 fields · synced May 18, 2026
- FDA UDI 86e1c822-9256-424b-9f8f-902114618bd6 34 fields · synced May 25, 2026
- FDA UDI 7eeb5212-0303-44b8-a8cb-262f31c075fa 34 fields · synced May 30, 2026
- FDA UDI b8fccc5e-7fbc-4791-84f4-2334cd62afac 34 fields · synced May 30, 2026
- FDA UDI 14556e73-a0c4-430c-b3e8-568576b6660c 34 fields · synced May 30, 2026
- FDA UDI 58ecedd2-8722-42f1-85e5-67907e82e3f1 34 fields · synced May 30, 2026
- FDA UDI 3f0a24f1-4d0f-4801-a130-4ab2df7cc686 34 fields · synced May 30, 2026
- EUDAMED 13be18eb-c786-43a8-8c08-319a6056e41c 61 fields · synced Jul 8, 2026
- EUDAMED dd3cdf9b-814e-41ef-aed3-93eeb5133a91 61 fields · synced Jul 9, 2026
- EUDAMED d96c88da-94bd-4c0c-80b0-27aba872024a 61 fields · synced Jul 10, 2026
- EUDAMED 175d33b7-1682-4956-b98c-cc15dab1bcf4 61 fields · synced Jul 14, 2026
- EUDAMED a3193da4-32fd-407a-8bfc-779d0956e82e 61 fields · synced Jul 17, 2026
- EUDAMED fa34d7d9-50dc-4367-8f29-6da4727d1630 61 fields · synced Jul 17, 2026
- EUDAMED e264274c-a043-4623-a93d-3bea25ed113e 61 fields · synced Jul 25, 2026
- EUDAMED 44f26725-6a91-40d3-aa7a-c98028afd1af 61 fields · synced Jul 26, 2026
- EUDAMED 4e92aaf9-cf2d-4011-a058-26fdd5342203 61 fields · synced Aug 2, 2026