Catheter, Ventricular
The Ventricular Catheter is a neurosurgical device inserted into the cerebral ventricles to drain cerebrospinal fluid, monitor intracranial pressure, or deliver medications, most commonly used in patients with hydrocephalus or following traumatic brain injury. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is HCA under regulation 21 CFR 882.4100 in the Neurology specialty. It is eligible for third-party 510(k) review.
Basic Information
- Product Code
- HCA
- Device Class
- FDA class 2
- Regulation Number
- 882.4100
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K161731 | Cleveland Multiport Ventricular Catheter Set | Mar 27, 2017 | Substantially Equivalent | Parker Hannifin Corp. |
| K123605 | SMARTFLOW CATHETER | Aug 16, 2013 | Substantially Equivalent | MRI INTERVENTIONS, INC. |
| K031123 | CODMAN BACTISEAL BARIUM STRIPED CATHETERS | May 14, 2003 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K021481 | BRESAGEN CATHETER, MODEL CS-3000 | Aug 06, 2002 | Substantially Equivalent | BRESAGEN, INC. |
| K020728 | MIETHKE SHUNT SYSTEM | Apr 05, 2002 | Substantially Equivalent | AESCULAP, INC. |
| K013005 | ACT 11 MP VENTRICULAR CATHETER | Mar 08, 2002 | Substantially Equivalent | INNERSPACE, INC. |
| K003322 | CODMAN BACTISEAL CATHETERS | Oct 01, 2001 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K992796 | ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000 | Oct 25, 1999 | Substantially Equivalent | IMAGE-GUIDED NEUROLOGICS, INC. |
| K983331 | MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102 | Dec 16, 1998 | Substantially Equivalent | MEDTRONIC PS MEDICAL |
| K834477 | DISPOS. SCOTT CANNULAS 16-1054 ETC. | Mar 19, 1984 | Substantially Equivalent | Codman & Shurtleff, Inc. |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.