PSN HEMODIALYZER, MODELS PSN 170, PSN 210— 510(k) K001422

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K001422 for PSN HEMODIALYZER, MODELS PSN 170, PSN 210, Substantially Equivalent on 2000-06-02. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2000-05-05
Decision date: 2000-06-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Mcgaw Park, IL, US

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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.