PO 2 LYTRODE— 510(k) K843538

Substantially Equivalent

Polystan C/O Vitalcor, Inc.

FDA 510(k) clearance K843538 for PO 2 LYTRODE, Substantially Equivalent on 1984-10-18. Applicant: Polystan C/O Vitalcor, Inc..

Clearance details

Applicant: Polystan C/O Vitalcor, Inc.
Product code: Code DRY
Advisory panel: Cardiovascular
Date received: 1984-09-07
Decision date: 1984-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ballerup Denmark, US

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Adverse events under product code DRY

product code DRY

Death: 5
Total: 5

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.