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LLD #1 Lead Locking Device 518-021

by Spectranetics Corporation

Ref 518-021

LLD #1 Lead Locking Device 518-021 is a device classified as Class IIa in the EU and Class II in the US made by Spectranetics Corporation, registered in EUDAMED on 2 May 2025 (Basic UDI-DI B-00813132023003) and listed in FDA GUDID since 1 Sep 2015 (UDI-DI 00813132023003), active as of 22 Oct 2026.

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

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00813132023003 Basic UDI-DI 00813132023003UDI-DIDate2 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00813132023003 UDI-DI Date1 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00813132023003 registered 2 May 2025 Active
  • FDA GUDID UDI-DI 00813132023003 listed 1 Sep 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00813132023003
  2. Registered EUDAMED B-00813132023003

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  • Withdrawn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
LLD #1 Lead Locking Device
Generic name
Pacing/defibrillation lead stylet
Device name
LLD Lead Locking Device
Model / Ref / Catalog
518-021
Primary DI / UDI-DI
00813132023003
Basic UDI-DI
B-00813132023003
FDA product code
DRB
EMDN code
C01901903 Vessel harvesting systems
GMDN term
Pacing/defibrillation lead stylet
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.1380
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 0.012 Inch

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Pacing/defibrillation lead stylet

Similar devices

Also classified as Pacing/defibrillation lead stylet.

Similar devices in this category

Other devices filed under SYSTEMS FOR VESSEL EXTRACTION AND VEIN CLOSURE.

Other devices from Spectranetics Corporation

See all devices from Spectranetics Corporation →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)