Skip to content

Peripheral Intervenous Catheter

by Medical Profiles, Inc.

510(k) K914378

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

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)SEKD Traditional NumberK914378 Date20 May 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
SEKD

Overview

AI-generated summary, 28 Sep 2026

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

A peripheral intervenous catheter is a device intended for insertion into a peripheral vein to provide vascular access for the administration of fluids, medications, or blood products. It is designed for short-term use in clinical settings to support patient care.

This device is supplied as a single-use, sterile product and is intended for use in general hospital environments. It is not MRI safe unless explicitly stated otherwise, and storage conditions should follow manufacturer guidelines. The device received FDA 510(k) clearance under K914378 with product code FOZ.

Other devices from Medical Profiles, Inc.

Questions

AI-generated answers, 28 Sep 2026

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

  • What is a peripheral intervenous catheter used for?

    A peripheral intervenous catheter is designed for insertion into a peripheral vein to provide vascular access for the administration of fluids, medications, or blood products in clinical settings.

  • Is the peripheral intervenous catheter single-use or reusable?

    This device is supplied as a single-use, sterile product and is intended for short-term use in general hospital environments.

  • What are the storage conditions for the peripheral intervenous catheter?

    Storage conditions should follow manufacturer guidelines, though specific details are not provided in the device data.

  • What regulatory approval does the peripheral intervenous catheter have?

    The device received FDA 510(k) clearance under K914378 with product code FOZ, indicating it meets safety and effectiveness requirements for its intended use.