Skip to content

Racz Epidural Catheter

by Medic Evaluation Devices & Instruments Corp.

510(k) K954584

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 NumberK954584 Date8 Oct 1996ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1276-2021 FDA Class II initiated 1 Feb 2021

    Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off

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  • Withdrawn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
BSO
Device Class
Class II
Regulation
21 CFR Part 868.5120
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent