# K962300: Clampless Valved Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Bmw Medical, Inc.
- Decided: Sep 5, 1996 after 84 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Hickman/Broviac catheters: named in the summary without a submission number
- (no number) Groshong valved catheters: named in the summary without a submission number

## Recalls of this device
- Oct 28, 2005 · Not classified · Z-0342-06: Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths.
- Oct 28, 2005 · Not classified · Z-0341-06: Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths.
- Jul 22, 2005 · Not classified · Z-1509-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1510-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1511-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

## Indications for use
BMW's central venous catheters are designed for the administration of I.V. fluids, blood products, drugs, and parenteral nutrition solutions, as well as for blood withdrawal.

Source page: https://510kreport.com/device/K962300
Methodology: https://510kreport.com/methodology