PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236— 510(k) K980656

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K980656 for PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236, Substantially Equivalent on 1998-05-19. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 1998-02-19
Decision date: 1998-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcgaw Park, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KDI

product code KDI

Death: 352
Injury: 1,474
Malfunction: 12,534
Other: 4
Total: 14,364

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.