POLYSTAN HEATER-COOLER UNIT— 510(k) K893940

Substantially Equivalent

Polystan C/O Vitalcor, Inc.

FDA 510(k) clearance K893940 for POLYSTAN HEATER-COOLER UNIT, Substantially Equivalent on 1990-01-18. Applicant: Polystan C/O Vitalcor, Inc..

Clearance details

Applicant: Polystan C/O Vitalcor, Inc.
Product code: Code DWC
Advisory panel: Cardiovascular
Date received: 1989-05-31
Decision date: 1990-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denmark, DK

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Adverse events under product code DWC

product code DWC

Death: 124
Injury: 233
Malfunction: 3,727
Total: 4,084

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.