510(k) K944354— CONTOUR EMBOLI

Substantially Equivalent

Interventional Therapeutics Corp.

Clearance details

Applicant: Interventional Therapeutics Corp.
Product code: Code HCG
Advisory panel: Neurology
Date received: 1994-08-30
Decision date: 1994-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Adverse events under product code HCG

product code HCG

Death: 50
Injury: 801
Malfunction: 5,625
Total: 6,476

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.