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Cato First Picc-Dual Lumen

by Catco Medical, Inc.

510(k) K944685

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)SESE Substantially Equivalent · Traditional NumberK944685 Date31 Mar 1995ClearedStatusActive

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  • Withdrawn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
LJS
Device Class
Class II
Regulation
21 CFR Part 880.5970
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

The Cato First Picc-Dual Lumen is a catheter, intravascular, therapeutic, long-term greater than 30 days. It is a dual lumen peripherally inserted central catheter designed for vascular access.

The device is supplied by Catco Medical, Inc. and is classified as a Class II medical device with product code LJS. It received FDA 510(k) clearance on March 31, 1995, with the regulation number 880.5970. The device is intended for use in general hospital settings.

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See all devices from Catco Medical, Inc. →

Questions

AI-generated answers, 27 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 the Cato First PICC-Dual Lumen used for?

    The Cato First PICC-Dual Lumen is a dual lumen peripherally inserted central catheter designed for vascular access, intended for therapeutic use in general hospital settings for long-term periods greater than 30 days.

  • How is the Cato First PICC-Dual Lumen supplied?

    The device is supplied by Catco Medical, Inc. and is classified as a Class II medical device with product code LJS. It is designed for use in general hospital settings.

  • What is the regulatory status of the Cato First PICC-Dual Lumen?

    The Cato First PICC-Dual Lumen received FDA 510(k) clearance on March 31, 1995, with regulation number 880.5970. It is classified as a Class II medical device with product code LJS.

  • Is the Cato First PICC-Dual Lumen reusable or single-use?

    The device description does not specify whether the Cato First PICC-Dual Lumen is designed for single-use or multiple uses. For specific usage instructions, please refer to the manufacturer's guidelines or contact Catco Medical, Inc.