MOBIMED SYSTEM, (PEGASUS AND POLARIS)— 510(k) K973318

Substantially Equivalent

Ortivus Us, Inc.

FDA 510(k) clearance K973318 for MOBIMED SYSTEM, (PEGASUS AND POLARIS), Substantially Equivalent on 1998-02-19. Applicant: Ortivus Us, Inc..

Clearance details

Applicant: Ortivus Us, Inc.
Product code: Code MSX
Advisory panel: Cardiovascular
Date received: 1997-09-04
Decision date: 1998-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis,, MN, 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.