Home / 510(k) Clearances / K223198

510(k) K223198

BD Intraosseous Vascular Access System EMS Powered Driver (D001003) by Bard Access Systems — Product Code MHC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2022
Date Received
October 13, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Interosseous
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Bard Access Systems

  • K252478 — Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Inj (September 5, 2025)
  • K251253 — PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M. (June 18, 2025)
  • K241353 — PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set (November 27, 2024)
  • K242328 — PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implan (October 31, 2024)
  • K240146 — BD Prevue™ II Peripheral Vascular Access System (February 18, 2024)
  • K222232 — Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly (August 24, 2022)
  • K210264 — BD PowerPiCC Catheter (July 30, 2021)
  • K120882 — SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE (May 30, 2012)
  • K100402 — SITE-RITE VISION ULTRASOUND SYSTEM (March 5, 2010)
  • K071095 — ASPIRA PLEURAL DRAINAGE SYSTEM (May 18, 2007)

Other clearances for product code MHC

  • K203193 — BD Intraosseous Infusion System (March 4, 2021)