SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER— 510(k) K140318

Substantially Equivalent

Biosense Webster

FDA 510(k) clearance K140318 for SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER, Substantially Equivalent on 2014-03-12. Applicant: Biosense Webster.

Clearance details

Applicant: Biosense Webster
Product code: Code OBJ
Advisory panel: Cardiovascular
Date received: 2014-02-10
Decision date: 2014-03-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Diamond Bar, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OBJ

product code OBJ

Death: 38
Injury: 634
Malfunction: 3,453
Total: 4,125

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.