SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II— 510(k) K894103

Substantially Equivalent

Scimed Life Systems, Inc.

FDA 510(k) clearance K894103 for SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II, Substantially Equivalent on 1989-09-21. Applicant: Scimed Life Systems, Inc..

Clearance details

Applicant: Scimed Life Systems, Inc.
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 1989-06-09
Decision date: 1989-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, 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.