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FDA 510(k)

BD Intraosseous Infusion System

K-Number: K203193 · 2021-03-04

Decision Date2021-03-04
Product CodeMHC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD Intraosseous Infusion System is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]. It received FDA 510(k) clearance on 2021-03-04 under 510(k) 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. The listed applicant is Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]. The 510(k) number is K203193.

When did BD Intraosseous Infusion System receive FDA 510(k) clearance?

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

Who is the listed applicant for BD Intraosseous Infusion System?

The FDA 510(k) record lists Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd] as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: MHC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.