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Supercath Z3V

by Togo Medikit Co., Ltd. 2 variants

510(k) K112290

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK112290 Date16 Apr 2012ClearedStatusActive

Official records

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  • Withdrawn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
FOZ
Device class
Class II
Regulation
21 CFR Part 880.5200
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Supercath Z3v is an intravascular catheter classified as a therapeutic, short-term device intended for use less than 30 days. It falls under the product code FOZ and is regulated under 21 CFR 880.5200 as a general hospital and personal use therapeutic device.

The device received traditional 510(k) clearance from the FDA under K112290, with a decision date of April 16, 2012, and was found substantially equivalent to predicate devices. It is manufactured by Togo Medikit Co., Ltd. and is intended for general hospital use.

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