510(k) K101669— THERMODILUTION CATHETER

Substantially Equivalent

Biosensors Intl. Pte. , Ltd.

Clearance details

Applicant: Biosensors Intl. Pte. , Ltd.
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 2010-06-14
Decision date: 2010-07-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Singapore, SG

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.