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Stream Line I.V. Catheter Placement Unit

by Menlo Care, Inc. 510(k)

Active United States

510(k) K860474

Overview

The Stream Line I.V. Catheter Placement Unit is an intravascular, therapeutic, short-term catheter intended for use for less than 30 days. It is designed to facilitate the placement of intravenous catheters within a clinical setting.

This device is identified by FDA 510(k) number K860474 and is classified under product code FOZ. It received traditional FDA 510(k) clearance on May 6, 1986, under the regulation for short-term intravascular therapeutic catheters.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK860474 Date6 May 1986ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

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