SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12— 510(k) K092064

Substantially Equivalent

Biosense Webster, Inc.

FDA 510(k) clearance K092064 for SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12, Substantially Equivalent on 2009-08-07. Applicant: Biosense Webster, Inc..

Clearance details

Applicant: Biosense Webster, Inc.
Product code: Code OBJ
Advisory panel: Cardiovascular
Date received: 2009-07-08
Decision date: 2009-08-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Diamond Bar, CA, US

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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.