HEPARIN-COATED EXTRACORPOREAL CIRCUITS— 510(k) K861641

Substantially Equivalent

American Bentley

FDA 510(k) clearance K861641 for HEPARIN-COATED EXTRACORPOREAL CIRCUITS, Substantially Equivalent on 1986-09-29. Applicant: American Bentley.

Clearance details

Applicant: American Bentley
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 1986-04-30
Decision date: 1986-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.