VERTEBRAL ACCESS SYSTEM BY VIDACARE— 510(k) K081713
Substantially EquivalentVidacare Corporation
FDA 510(k) clearance K081713 for VERTEBRAL ACCESS SYSTEM BY VIDACARE, Substantially Equivalent on 2008-11-21. Applicant: Vidacare Corporation. Device class: 1.
Clearance details
- Applicant
- Vidacare Corporation
- Product code
- Code MOQ
- Device class
- Class 1
- Regulation
- 21 CFR 878.4820
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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- K091140 — EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO
Adverse events under product code MOQ
product code MOQ- Malfunction
- 1,643
- Total
- 1,643
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.