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FDA 510(k)

BD Intraosseous Vascular Access System EMS Powered Driver (D001003)

K-Number: K223198 · 2022-11-10

ApplicantBard Access Systems
Decision Date2022-11-10
Product CodeMHC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD Intraosseous Vascular Access System EMS Powered Driver (D001003) is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems. It received FDA 510(k) clearance on 2022-11-10 under 510(k) number K223198. 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 Vascular Access System EMS Powered Driver (D001003)?

BD Intraosseous Vascular Access System EMS Powered Driver (D001003) is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Bard Access Systems. The 510(k) number is K223198.

When did BD Intraosseous Vascular Access System EMS Powered Driver (D001003) receive FDA 510(k) clearance?

BD Intraosseous Vascular Access System EMS Powered Driver (D001003) received FDA 510(k) clearance on 2022-11-10, under 510(k) number K223198.

Who is the listed applicant for BD Intraosseous Vascular Access System EMS Powered Driver (D001003)?

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

What is the FDA product code for BD Intraosseous Vascular Access System EMS Powered Driver (D001003)?

The FDA product code for BD Intraosseous Vascular Access System EMS Powered Driver (D001003) is MHC.

Related Clinical Trials

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.

NCT01866501Follow-Up Study Validating a Blended Technique to Identify the Proximal Humerus Intraosseous Vascular Access SiteCOMPLETEDNCT01866514Proximal Humerus Site for AnesthesiaCOMPLETEDNCT07471555Vascular Access and IntraosseusENROLLING_BY_INVITATION

Other records listing Bard Access Systems as applicant

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.

K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable PortK251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable PortK241353PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle SetK242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable PortsK240146BD Prevue™ II Peripheral Vascular Access SystemK222232Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly

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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.

K203193BD Intraosseous Infusion SystemBard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]

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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