HCD · Cannula, Ventricular
Neurology · 21 CFR 882.4060 · Class 1
Overview
| Product Code | HCD |
|---|---|
| Device Name | Cannula, Ventricular |
| Regulation | 21 CFR 882.4060 |
| Device Class | Class 1 |
| Review Panel | Neurology |
Identification
A ventricular cannula is a device used to puncture the ventricles of the brain for aspiration or for injection. This device is frequently referred to as a ventricular needle.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K150660 | Alcyone MEMS Cannula (AMC) System | Alcyone Lifesciences, Inc. | Apr 16, 2015 | SESE |
| K102101 | SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA | Surgivision, Inc. | Jan 26, 2011 | SESE |
| K920088 | CAMINO VENTRICULAR NEEDLE | Camino Laboratories, Inc. | May 1, 1992 | SESE |
Top Applicants
- Alcyone Lifesciences, Inc. — 1 clearance
- Camino Laboratories, Inc. — 1 clearance
- Surgivision, Inc. — 1 clearance
