P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR— 510(k) K961706

Substantially Equivalent

Fresenius USA, Inc.

FDA 510(k) clearance K961706 for P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR, Substantially Equivalent on 1996-07-31. Applicant: Fresenius USA, Inc..

Clearance details

Applicant: Fresenius USA, Inc.
Product code: Code LKN
Advisory panel: Unknown
Date received: 1996-05-02
Decision date: 1996-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walnut Creek, CA, US

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Adverse events under product code LKN

product code LKN

Death: 50
Injury: 314
Total: 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.