CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100— 510(k) K870804

Substantially Equivalent

American Bentley

FDA 510(k) clearance K870804 for CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100, Substantially Equivalent on 1987-09-01. Applicant: American Bentley.

Clearance details

Applicant: American Bentley
Product code: Code DTR
Advisory panel: Cardiovascular
Date received: 1987-02-27
Decision date: 1987-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTR

product code DTR

Other: 1
Total: 1

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.