OXTI INFLATION DEVICE— 510(k) K122152
Substantially EquivalentOxti Corporation
FDA 510(k) clearance K122152 for OXTI INFLATION DEVICE, Substantially Equivalent on 2012-12-14. Applicant: Oxti Corporation. Device class: 2.
Clearance details
- Applicant
- Oxti Corporation
- Product code
- Code MAV
- Device class
- Class 2
- Regulation
- 21 CFR 870.1650
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, US
Recent devices under product code MAV
view all- K260035 — Digital Indeflator INFLANTE
- K220773 — Everest 20 Inflation Device and 3-way Stopcock (AC2200) +3 more
- K162272 — Fluent inflation device
- K153038 — Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
- K153672 — basixTOUCH40 Inflation Syringe
Adverse events under product code MAV
product code MAV- Malfunction
- 1,433
- Total
- 1,433
Source: openFDA MAUDE database, through . 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.