TUBULAR HOLLOW FIBER MEMBRANE— 510(k) K841476

Substantially Equivalent

American Bentley

FDA 510(k) clearance K841476 for TUBULAR HOLLOW FIBER MEMBRANE, Substantially Equivalent on 1984-08-03. Applicant: American Bentley.

Clearance details

Applicant: American Bentley
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 1984-04-09
Decision date: 1984-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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.