INFINITY EXPLORER— 510(k) K013515

Substantially Equivalent

Siemens Medical Solutions USA, Inc.

FDA 510(k) clearance K013515 for INFINITY EXPLORER, Substantially Equivalent on 2002-01-10. Applicant: Siemens Medical Solutions USA, Inc..

Clearance details

Applicant: Siemens Medical Solutions USA, Inc.
Product code: Code DXJ
Advisory panel: Cardiovascular
Date received: 2001-10-22
Decision date: 2002-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

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Adverse events under product code DXJ

product code DXJ

Death: 2
Total: 2

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.