THERMAL DILUTION CATHETER— 510(k) K843411

Substantially Equivalent

Andover Medical, Inc.

FDA 510(k) clearance K843411 for THERMAL DILUTION CATHETER, Substantially Equivalent on 1984-10-18. Applicant: Andover Medical, Inc..

Clearance details

Applicant: Andover Medical, Inc.
Product code: Code DYG
Advisory panel: Cardiovascular
Date received: 1984-08-31
Decision date: 1984-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lawrence, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DYG

product code DYG

Death: 18
Malfunction: 1,051
Other: 1
Total: 1,070

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.