PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR— 510(k) K901250

Substantially Equivalent

Shiley, Inc.

FDA 510(k) clearance K901250 for PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR, Substantially Equivalent on 1990-06-11. Applicant: Shiley, Inc..

Clearance details

Applicant: Shiley, Inc.
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 1990-03-16
Decision date: 1990-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.