# K001633: Lifesite Hemodialysis Access System/Cannula Exchange, Model LHAS14120 & LHCEK0000

- Pathway: 510(k) (Traditional)
- Applicant: Vasca, Inc.
- Decided: Aug 24, 2000 after 90 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K821684 (1982). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K821684: MCSCP8PS with 'Y' Hub, Medical Components, Inc. (1982) Summary page 1.
- K913235: Davol Implant Ports W/Attach HI Perf Groshong Cath, Davol, Inc. (1991) Summary page 1.

## Recalls of this device
- Sep 22, 2003 · Not classified · Z-0045-04: Outer kit mislabeled with an extended expiration date

## Indications for use
The LifeSite® Hemodialysis Access System provides fully-implantable blood access for patients who require hemodialysis while waiting for creation and/or maturation of permanent access. A 70% isopropyl alcohol solution is used in conjunction with the LifeSite System for the localized cleansing of the injection site, valve pocket, and LifeSite valve.

Source page: https://510kreport.com/device/K001633
Methodology: https://510kreport.com/methodology