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DKutting LL Peripheral Scoring Balloon Dilatation Catheter

by DK Medical Technology Co., Ltd. 42 variants

Ref DKL14-3040B, DKL14-3540B, DKL14-30150D, DKL14-25150B, DKL14-25120D, DKL18-40150B, DKL18-40120C, DKL14-3540D, DKL18-45150C, DKL18-45120C, DKL14-2580D, DKL18-40150C, DKL18-60150C, DKL18-50120C, DKL14-2540D, DKL14-2560B, DKL14-35120D, DKL14-2540B, DKL18-65120B, DKL14-35120C, DKL14-2560D, DKL18-5540D, DKL14-25120C, DKL18-50120D, DKL14-3020B, DKL14-25100B, DKL18-6560B, DKL18-55100C, DKL18-7060D, DKL14-30120B, DKL18-50100B, DKL18-6080D, DKL18-5560D, DKL18-6580C, DKL18-6580D, DKL18-4080D, DKL14-2580C, DKL14-25150C, DKL18-4060D, DKL18-65100C, DKL14-30120C, DKL18-7020C, DKL18-5580D, DKL14-2560C, DKL18-65120D, DKL18-4060C, DKL14-2520C, DKL18-45150B, DKL18-6040C, DKL18-7040C, DKL18-5520B

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K242254↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6923533815DKLCL Basic UDI-DI Date26 Jun 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK242254 Date21 Apr 2025IssuedStatusActive

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 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Device Name
Peripheral Scoring Balloon Dilatation Catheter
Model / Reference
DKL14-3040B, DKL14-3540B, DKL14-30150D, DKL14-25150B, DKL14-25120D, DKL18-40150B, DKL18-40120C, DKL14-3540D, DKL18-45150C, DKL18-45120C, DKL14-2580D, DKL18-40150C, DKL18-60150C, DKL18-50120C, DKL14-2540D, DKL14-2560B, DKL14-35120D, DKL14-2540B, DKL18-65120B, DKL14-35120C, DKL14-2560D, DKL18-5540D, DKL14-25120C, DKL18-50120D, DKL14-3020B, DKL14-25100B, DKL18-6560B, DKL18-55100C, DKL18-7060D, DKL14-30120B, DKL18-50100B, DKL18-6080D, DKL18-5560D, DKL18-6580C, DKL18-6580D, DKL18-4080D, DKL14-2580C, DKL14-25150C, DKL18-4060D, DKL18-65100C, DKL14-30120C, DKL18-7020C, DKL18-5580D, DKL14-2560C, DKL18-65120D, DKL18-4060C, DKL14-2520C, DKL18-45150B, DKL18-6040C, DKL18-7040C, DKL18-5520B
Primary DI / UDI-DI
06923533801279, 06923533801484, 06923533801460, 06923533801118, 06923533801248, 06923533801743, 06923533801804, 06923533801620, 06923533802023, 06923533802016, 06923533801224, 06923533801811, 06923533802658, 06923533802221, 06923533801200, 06923533801071, 06923533801668, 06923533801064, 06923533802788, 06923533801590, 06923533801217, 06923533802467, 06923533801170, 06923533802290, 06923533801262, 06923533801095, 06923533802757, 06923533802429, 06923533803105, 06923533801316, 06923533802146, 06923533802696, 06923533802474, 06923533802832, 06923533802900, 06923533801859, 06923533801156, 06923533801187, 06923533801842, 06923533802849, 06923533801385, 06923533803013, 06923533802481, 06923533801149, 06923533802924, 06923533801774, 06923533801125, 06923533801958, 06923533802603, 06923533803020, 06923533802313
Basic UDI-DI
6923533815DKLCL
EMDN Code
C010402020199 PTA dilatation catheters - other
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000011218
Authorised representative
MedPath GmbH DE-AR-000000087

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Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No