Skip to content

Meditronic Andover Medical Model 1690 Electrode

by Medtronic Andover Medical, Inc.

510(k) K905446

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK905446 Date5 Feb 1991ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1185-03 FDA Unclassified (pre-2012) initiated 30 Jul 2003

    Separation of the sensing element from the body of the electrode.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DRX
Device Class
Class II
Regulation
21 CFR Part 870.2360
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Medtronic Andover Medical, Inc.