ACUSON ACUNAV 8F ULTRASOUND CATHETER— 510(k) K042593

Substantially Equivalent

Siemens Medical Solutions USA, Inc.

FDA 510(k) clearance K042593 for ACUSON ACUNAV 8F ULTRASOUND CATHETER, Substantially Equivalent on 2004-10-15. Applicant: Siemens Medical Solutions USA, Inc..

Clearance details

Applicant: Siemens Medical Solutions USA, Inc.
Product code: Code OBJ
Advisory panel: Cardiovascular
Date received: 2004-09-23
Decision date: 2004-10-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Mountain View, 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.