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Temporary Bipolar Myocardial Pacing Wire

by European Custom Manufacturing BV 510(k)

Active United States

510(k) K033858

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK033858 Date12 Jul 2004ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-1038-2012 FDA Unclassified (pre-2012) initiated 18 Apr 2011

    The crimping operation during product production was not performed properly. As such, the pacing wire may separate from the connection pin, which causes non-functionality.

Specification

510(k)

510(k) Number
FDA Product Code
LDF
Device Class
Class II
Regulation
21 CFR Part 870.3680
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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