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Clampless Valved Catheter

by Bmw Medical, Inc. 510(k)

Active United States

510(k) K962300

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK962300 Date5 Sep 1996ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

5 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0341-06 FDA Unclassified (pre-2012) initiated 28 Oct 2005
    • Terminated Z-0342-06 FDA Unclassified (pre-2012) initiated 28 Oct 2005

    Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths.

  • 3 recalls, same reason

    • Terminated Z-1511-05 FDA Unclassified (pre-2012) initiated 22 Jul 2005 on shared 510(k) K962300
    • Terminated Z-1509-05 FDA Unclassified (pre-2012) initiated 22 Jul 2005 on shared 510(k) K962300
    • Terminated Z-1510-05 FDA Unclassified (pre-2012) initiated 22 Jul 2005 on shared 510(k) K962300

    The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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, 23 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 Clampless Valved Catheter is a type of catheter, specifically an intravascular, therapeutic, long-term catheter for use greater than 30 days. It is designed to provide clampless valve features on an open-ended catheter.

The device is supplied for use in establishing venous access, and is effective for administration of fluids and blood products, as well as blood specimen withdrawal. The catheter is regulated under product code LJS and regulation number 880.5970, and has been cleared under FDA 510(k) number K962300.

Other devices from Bmw Medical, Inc.

Questions

AI-generated answers, 23 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 Clampless Valved Catheter used for?

    The Clampless Valved Catheter is used for establishing venous access, administration of fluids and blood products, and blood specimen withdrawal.

  • Is the Clampless Valved Catheter supplied sterile?

    The description does not explicitly state that the device is supplied sterile, but it is intended for use in establishing venous access and administering fluids and blood products, which implies a need for sterility.

  • What is the regulatory classification of the Clampless Valved Catheter?

    The Clampless Valved Catheter is regulated under product code LJS and regulation number 880.5970.