# K971085: Soft Tip Multi-Lumen Central Venous Catheter

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Jun 2, 1997 after 69 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices 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) Accuguide Multi-Lumen Central Venous Catheter Kit: named in the summary without a submission number

## Most influential descendants
- K021130: Specath Central Venous Catheter Kits (2003), 2 descendants of its own
- K070451: Able Central Venous Catheter (2007), 1 descendant of its own
- K193158: ACENT™ Central Venous Catheter (2020), 0 descendants of its own
- K023253: Pediatric Central Venous Catheter Kit (2003), 0 descendants of its own

## Recalls of this device
- Apr 16, 2004 · Not classified · Z-1133-04: Catheter separated from the hub.

## Indications for use
The soft Tip Multi-Lumen Catheter is a device that is inserted into the venous system for the administration of blood products, parenteral nutrition, I.V. fluids or drugs.

Source page: https://510kreport.com/device/K971085
Methodology: https://510kreport.com/methodology