FDA Product Code MHC: Needle, Interosseous
Leading manufacturers include Bard Access Systems and Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd].
2
Total
2
Cleared
78d
Avg days
2021
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Needle, Interosseous Devices (Product Code MHC)
2 devices
Cleared
Nov 10, 2022
BD Intraosseous Vascular Access System EMS Powered Driver (D001003)
Bard Access Systems
General Hospital
28d
Cleared
Mar 04, 2021
BD Intraosseous Infusion System
Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]
General Hospital
127d
About Product Code MHC - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code MHC since 2021, with 2 receiving FDA clearance (average review time: 78 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
MHC devices are reviewed by the General Hospital panel. Browse all General Hospital devices →