FDA 510(k)

FAST1 Intraosseous Infusion System; FASTResponder Sternal Intraosseous Device

K-Number: K180588 · 2018-04-17

Decision Date2018-04-17

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

FAST1 Intraosseous Infusion System; FASTResponder Sternal Intraosseous Device is a medical device manufactured by Teleflex Medical. It received FDA 510(k) clearance on 2018-04-17 under approval number K180588. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FAST1 Intraosseous Infusion System; FASTResponder Sternal Intraosseous Device?

FAST1 Intraosseous Infusion System; FASTResponder Sternal Intraosseous Device is a medical device that received FDA 510(k) clearance on 2018-04-17. It is manufactured by Teleflex Medical. The 510(k) number is K180588.

When was FAST1 Intraosseous Infusion System; FASTResponder Sternal Intraosseous Device approved by the FDA?

FAST1 Intraosseous Infusion System; FASTResponder Sternal Intraosseous Device received FDA 510(k) clearance on 2018-04-17, under approval number K180588.

What company makes FAST1 Intraosseous Infusion System; FASTResponder Sternal Intraosseous Device?

FAST1 Intraosseous Infusion System; FASTResponder Sternal Intraosseous Device is manufactured by Teleflex Medical.

What is the FDA product code for FAST1 Intraosseous Infusion System; FASTResponder Sternal Intraosseous Device?

The FDA product code for FAST1 Intraosseous Infusion System; FASTResponder Sternal Intraosseous Device is FMI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.