Deltaven XiV Max, Deltaven XiV Max FF— 510(k) K171530

Substantially Equivalent

Delta Med Spa

FDA 510(k) clearance K171530 for Deltaven XiV Max, Deltaven XiV Max FF, Substantially Equivalent on 2017-12-21. Applicant: Delta Med Spa.

Clearance details

Applicant: Delta Med Spa
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 2017-05-25
Decision date: 2017-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Viadana, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

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.