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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 a medical device manufactured by Bard Access Systems. It received FDA 510(k) clearance on 2022-11-10 under approval 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. It is manufactured by Bard Access Systems. The 510(k) number is K223198.

When was BD Intraosseous Vascular Access System EMS Powered Driver (D001003) approved by the FDA?

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

What company makes BD Intraosseous Vascular Access System EMS Powered Driver (D001003)?

BD Intraosseous Vascular Access System EMS Powered Driver (D001003) is manufactured by Bard Access Systems.

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

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07548151 Guided Needle Insertion for Vascular Access COMPLETED NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT06099015 Cera™ Vascular Plug System Post-Market Clinical Follow-Up RECRUITING NCT06472518 Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs. RECRUITING NCT06904651 VADIOR: Advantages of Pre-operative Positioning of Peripherally Inserted Vascular Accesses in DIVA Patients Undergoing Orthopedic Surgery ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 40258332 Chronic expanding hematoma following Gamma Knife irradiation for primary central nervous system lymphoma: illustrative case. Journal of neurosurgery. Case lessons (2025) PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

Related Devices (Code: MHC)

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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