INFINITY EXPLORER— 510(k) K030615

Substantially Equivalent

Siemens Medical Solutions USA, Inc.

FDA 510(k) clearance K030615 for INFINITY EXPLORER, Substantially Equivalent on 2003-03-21. Applicant: Siemens Medical Solutions USA, Inc..

Clearance details

Applicant: Siemens Medical Solutions USA, Inc.
Product code: Code MSX
Advisory panel: Cardiovascular
Date received: 2003-02-26
Decision date: 2003-03-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Danvers, MA, US

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Adverse events under product code MSX

product code MSX

Death: 59
Total: 59

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.