# K970662: CA Cellulose Acetate Hollow Fiber Dialyzer (CA-170/CA-210)

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Mar 11, 1998 after 383 days
- Product code: MSF (Hemodialyzer, Re-Use, High Flux)
- Device class: 2
- Regulation: 21 CFR 876.5860
- 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) Baxter Dialyzers: named in the summary without a submission number

## Indications for use
Hemodialysis with these dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It may also be indicated in the treatment of patients intoxicated with poisons or drugs. This dialyzer is indicated for single use or reuse. If the dialyzer is reused on the same patient, the reuse procedure and disinfectant specified in the Direction Insert must be followed. No other reuse procedure or disinfectant has been evaluated for clinical acceptability.

Source page: https://510kreport.com/device/K970662
Methodology: https://510kreport.com/methodology