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Capsure® EPI 4965-35

by Medtronic, Inc. 2 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00681490116503 UDI-DI Date23 Sep 2014ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Capsure® EPI
Generic Name
Epicardial pacing lead
Model / Reference
4965-35
Primary DI / UDI-DI
00681490116503
PMA Number
FDA Product Code
NVN, NVY, DTB
GMDN Term
Epicardial pacing lead
Device Class
Class III
Regulation Number
870.3680
GUDID distribution status
Not in Commercial Distribution
Size
Length — 35.0 Centimeter

Related devices

Cleared under the same submission (P950024)

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

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

Other properties (8)

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