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FDA 510(k)

BD Intraosseous Infusion System

K-Number: K203193 · 2021-03-04

ApplicantBard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]
Decision Date2021-03-04
Product CodeMHC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD Intraosseous Infusion System is a medical device manufactured by Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]. It received FDA 510(k) clearance on 2021-03-04 under approval number K203193. The device is classified under product code MHC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Intraosseous Infusion System?

BD Intraosseous Infusion System is a medical device that received FDA 510(k) clearance on 2021-03-04. It is manufactured by Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]. The 510(k) number is K203193.

When was BD Intraosseous Infusion System approved by the FDA?

BD Intraosseous Infusion System received FDA 510(k) clearance on 2021-03-04, under approval number K203193.

What company makes BD Intraosseous Infusion System?

BD Intraosseous Infusion System is manufactured by Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd].

What is the FDA product code for BD Intraosseous Infusion System?

The FDA product code for BD Intraosseous Infusion System is MHC.

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Official Source

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

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