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CapSureFix MRI™ SureScan™ 5086MRI52

by Medtronic, Inc. EUDAMEDGUDID

Withdrawn European Union

Ref 5086MRI52

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/AIMDD EUDAMED NumberB-00613994475114 Basic UDI-DIDate22 Jul 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number00613994657367 UDI-DIDate23 Sep 2014ListedStatusListed GUDID: not in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/AIMDD Withdrawn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

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 on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
CapSureFix MRI™ SureScan™
Generic Name
Endocardial/interventricular septal pacing lead
Device Name
5086MRI CapSure Fix MRI Lead
Model / Reference
5086MRI52
Primary DI / UDI-DI
00613994657367, 00613994475114, 00613994475084
Basic UDI-DI
B-00613994475114, B-00613994475084, B-00613994657367
PMA Number
FDA Product Code
NVN, DTB, NVY
EMDN Code
J0190010102 Endocardial atrial and ventricular leads, bipolar (with active or passive fixation)
GMDN Term
Endocardial/interventricular septal pacing lead
Device Class
Class AIMDD EUDAMED
Class III GUDID
Regulation Number
870.3680
Market of Registration
Netherlands
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Conditional
Size
Length — 52.0 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class AIMDD
GUDID
Class III

Related devices

Cleared under the same submission (P090013)

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Incorporates Medicinal Product
  • Prescription Use
  • Combination Product
  • Serial Number

Other properties (17)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No