THERMODILUTION CATHETER— 510(k) K083384

Substantially Equivalent

Biosensors Intl. Pte. , Ltd.

FDA 510(k) clearance K083384 for THERMODILUTION CATHETER, Substantially Equivalent on 2010-01-05. Applicant: Biosensors Intl. Pte. , Ltd..

Clearance details

Applicant: Biosensors Intl. Pte. , Ltd.
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 2008-11-17
Decision date: 2010-01-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQO

product code DQO

Death: 35
Injury: 993
Malfunction: 1,772
Other: 5
Total: 2,805

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.