MHC · Needle, Interosseous
General Hospital · 21 CFR 880.5570 · Class 2
Overview
| Product Code | MHC |
|---|---|
| Device Name | Needle, Interosseous |
| Regulation | 21 CFR 880.5570 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| Implant | Yes |
Identification
A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K223198 | BD Intraosseous Vascular Access System EMS Powered Driver (D001003) | Bard Access Systems | Nov 10, 2022 | SESE |
| K203193 | BD Intraosseous Infusion System | Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd] | Mar 4, 2021 | SESE |
Top Applicants
- Bard Access Systems — 1 clearance
- Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd] — 1 clearance
