Cannula, Ventricular
The Ventricular Cannula is a surgical tube inserted into the cerebral ventricles to provide temporary access for cerebrospinal fluid drainage or to facilitate placement of indwelling catheter systems during neurosurgical procedures. It is classified as a Class 1 device (lowest risk), subject to general controls only. The product code is HCD under regulation 21 CFR 882.4060 in the Neurology specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.
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Basic Information
- Product Code
- HCD
- Device Class
- FDA class 1
- Regulation Number
- 882.4060
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K150660 | Alcyone MEMS Cannula (AMC) System | Apr 16, 2015 | Substantially Equivalent | Alcyone Lifesciences, Inc. |
| K102101 | SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA | Jan 26, 2011 | Substantially Equivalent | Surgivision, Inc. |
| K920088 | CAMINO VENTRICULAR NEEDLE | May 01, 1992 | Substantially Equivalent | Camino Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 21 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.