DUFLO CATHETER (HEPARIN COATED)— 510(k) K093847

Substantially Equivalent

Thermopeutix, Inc.

FDA 510(k) clearance K093847 for DUFLO CATHETER (HEPARIN COATED), Substantially Equivalent on 2010-08-25. Applicant: Thermopeutix, Inc..

Clearance details

Applicant: Thermopeutix, Inc.
Product code: Code MJN
Advisory panel: Cardiovascular
Date received: 2009-12-16
Decision date: 2010-08-25
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MJN

product code MJN

Death: 31
Injury: 240
Malfunction: 827
Total: 1,098

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.