Recently Teleflex received FDA 510(k) clearance to restate the Indications for Use statement and labeling to modify insertion sites for the ARROW EZ-IO System to include the distal femur for pediatric patents . Revised ARROW EZ-IO System Indications for Use: For intraosseous access any time where vascular access is difficult to obtain in emergent, urgent or medically necessary cases for up to 24 hours.
| Adults | Pediatrics |
- Proximal humerus
- Proximal tibia
- Distal tibia
|
- Distal femur
- Proximal humerus
- Proximal tibia
- Distal tibia
|
This indication provides expanded pediatric vascular access options in appropriate clinical situations and was developed with input from our clinicians and customers.
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