# K963215: Clampless Valved Catheter - Midline (CVC-ML)

- Pathway: 510(k) (Traditional)
- Applicant: Bmw Medical, Inc.
- Decided: Nov 14, 1996 after 90 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: none
- 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) C. R. Bard, Inc., Groshong Peripherally Inserted Central Venous Catheter: named in the summary without a submission number
- (no number) HDC Corp.’s V-Cath® Midline Catheter: named in the summary without a submission number

## Indications for use
BMW'’s CVC Midline catheter is designed to establish peripheral venous access for administration of fluids including, but not limited to, hydration agents, antibiotics, analgesics, 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 peripheral intravenous therapy.

Source page: https://510kreport.com/device/K963215
Methodology: https://510kreport.com/methodology