SCIMED II MEMBRANE OXYGENATOR SYSTEM— 510(k) K843956

Substantially Equivalent

Scimed Life Systems, Inc.

FDA 510(k) clearance K843956 for SCIMED II MEMBRANE OXYGENATOR SYSTEM, Substantially Equivalent on 1985-01-08. Applicant: Scimed Life Systems, Inc..

Clearance details

Applicant: Scimed Life Systems, Inc.
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 1984-10-09
Decision date: 1985-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code DTZ

product code DTZ

Death: 182
Injury: 422
Malfunction: 3,636
Total: 4,240

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.