# K963806: Clampless Valved Catheter - Tunneled (CVC-T)

- Pathway: 510(k) (Traditional)
- Applicant: Bmw Medical, Inc.
- Decided: Dec 12, 1996 after 80 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: 2 (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) Groshong Multi-Lumen Central Venous Catheters: named in the summary without a submission number
- (no number) Hickman Multi-Lumen Central Venous Catheters: named in the summary without a submission number

## Recalls of this device
- Jul 22, 2005 · Not classified · Z-1508-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- May 25, 2004 · Not classified · Z-1112-05: Kits labeled to contain 0.028" guidewire contain 0.038" guidewire.

## Indications for use
BMW’s Clampless Valved Catheter-Tunneled is designed for patients who require long-term access to the central venous system for administration of fluids including, but not limited to, hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is effective for venous access in adults, children, and infants who require intravenous therapy.

Source page: https://510kreport.com/device/K963806
Methodology: https://510kreport.com/methodology