Skip to content

Renovocath RC120

by Renovorx, Inc.

510(k) K141175

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 NumberK141175 Date24 Oct 2014ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0565-2016 FDA Class II initiated 25 Nov 2015

    Incorrect version of Instructions for Use were shipped to two US customers.

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  • Withdrawn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
MJN
Device Class
Class II
Regulation
21 CFR Part 870.4450
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Renovorx, Inc.

  • RenovoCath

    Class II

  • RenovoCath

    Class II

  • RenovoCath

    Class II