# K030277: Soft-Cell Dual Lumen Catheters

- Pathway: 510(k) (Abbreviated)
- Applicant: C.R. Bard, Inc.
- Decided: Aug 6, 2003 after 191 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K871488 (1987). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871488: Vas-Cath Permanent Dual Lumen Hemodialysis Cath, Vas-Cath of Canada, Ltd. (1987) Summary page 1.

## Indications for use
The Vas-Cath Soft-Cell dual lumen hemodialysis catheter is indicated for use in attaining short term or long term vascular access for hemodialysis, hemoperfusion or apheresis therapy via the jugular or subclavian vein.

Source page: https://510kreport.com/device/K030277
Methodology: https://510kreport.com/methodology