Skip to content

FuStarTM Steerable introducer SVB10F-900

by Lifetech Scientific (Shenzhen) Co., Ltd.

Ref SVB10F-900

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06938370116813 Basic UDI-DI 06938370116813UDI-DIDate19 Dec 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number06938370116813 UDI-DI Date14 Nov 2017ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Fustar EUDAMED
FuStarTM Steerable introducer GUDID
Generic Name
Cardiac occluder delivery kit
Device Name
Fustar™ Steerable Introducer
Model / Reference
SVB10F-900
Primary DI / UDI-DI
06938370116813 EUDAMED
06938370117933 GUDID
Basic UDI-DI
B-06938370116813
510(k) Number
FDA Product Code
DQY
EMDN Code
P0780 Vascular and cardiac prostheses - accessories
GMDN Term
Cardiac occluder delivery kit
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1250
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06938370116813
GUDID
06938370117933
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K100184)

Show all (12)

Other devices from Lifetech Scientific (Shenzhen) Co., Ltd.

See all devices from Lifetech Scientific (Shenzhen) Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (15)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No