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FDA 510(k)

FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device

K-Number: K180588 · 2018-04-17

ApplicantTeleflex Medical
Decision Date2018-04-17
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2018-04-17 under 510(k) 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. The listed applicant is Teleflex Medical. The 510(k) number is K180588.

When did FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device receive FDA 510(k) clearance?

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

Who is the listed applicant for FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device?

The FDA 510(k) record lists Teleflex Medical as the applicant. This does not by itself establish the device manufacturer.

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.

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