OXTI INFLATION DEVICE— 510(k) K122152

Substantially Equivalent

Oxti Corporation

FDA 510(k) clearance K122152 for OXTI INFLATION DEVICE, Substantially Equivalent on 2012-12-14. Applicant: Oxti Corporation.

Clearance details

Applicant: Oxti Corporation
Product code: Code MAV
Advisory panel: Cardiovascular
Date received: 2012-07-20
Decision date: 2012-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAV

product code MAV

Malfunction: 1,433
Total: 1,433

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.