EZ-IO Intraosseous Vascular Access System
FDA 510(k) K180395 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
510(k) numberK180395
Submission
- Device name
- EZ-IO Intraosseous Vascular Access System
- Applicant
- Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
Reading, PA, US - Received
- February 13, 2018
- Decision date
- November 9, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
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Questions and answers
When was EZ-IO Intraosseous Vascular Access System cleared by the FDA?
EZ-IO Intraosseous Vascular Access System (K180395) received a 510(k) decision of Substantially Equivalent on November 9, 2018, 269 days after the submission was received.
What is the product code of K180395?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.