# K023023: Lifesite Hemodialysis Access System, Cannula Exchange Kit, Insertion Kit, Access Cannila

- Pathway: 510(k) (Traditional)
- Applicant: Vasca, Inc.
- Decided: Dec 4, 2003 after 449 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
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) LifeSite Hemodialysis Access System: named in the summary without a submission number
- (no number) Medical Components Inc. Tesio®-Cath Catheter: named in the summary without a submission number

## Indications for use
The LifeSite Hemodialysis Access System provides fully implantable blood access for chronic (long term) hemodialysis. It is intended for use in patients who would otherwise be treated with standard cuffed hemodialysis catheters. A 70% isopropyl alcohol solution is used in conjunction with the LifeSite System for the localized cleansing of the access site (buttonhole), valve pocket and LifeSite valve.

Source page: https://510kreport.com/device/K023023
Methodology: https://510kreport.com/methodology