FAST1 Intraosseous Infusion System; FASTResponder Sternal Intraosseous Device
FDA 510(k) K180588 · Teleflex Medical
510(k) numberK180588
Submission
- Device name
- FAST1 Intraosseous Infusion System; FASTResponder Sternal Intraosseous Device
- Applicant
- Teleflex Medical
Morrisville, NC, US - Received
- March 6, 2018
- Decision date
- April 17, 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 FAST1 Intraosseous Infusion System; FASTResponder Sternal Intraosseous Device cleared by the FDA?
FAST1 Intraosseous Infusion System; FASTResponder Sternal Intraosseous Device (K180588) received a 510(k) decision of Substantially Equivalent on April 17, 2018, 42 days after the submission was received.
What is the product code of K180588?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.