EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO
FDA 510(k) clearance K091140 · decided 2009-10-14
Clearance details
- K-number
- K091140
- Device name
- EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO
- Applicant
- Vidacare Corporation
- Decision
- Substantially Equivalent
- Date received
- 2009-04-20
- Decision date
- 2009-10-14
- Days to decision
- 177 days
- Clearance type
- Traditional
- Product code
- FMI
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079. recall (Z-1829-2017) | Teleflex Medical | 2017-04-04 |