HCA · Catheter, Ventricular
Neurology · 21 CFR 882.4100 · Class 2
Overview
| Product Code | HCA |
|---|---|
| Device Name | Catheter, Ventricular |
| Regulation | 21 CFR 882.4100 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain.
Classification Rationale
Class II (performance standards).
Cleared Devices (10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K161731 | Cleveland Multiport Ventricular Catheter Set | Parker Hannifin Corp. | Mar 27, 2017 | SESE |
| K123605 | SMARTFLOW CATHETER | Mri Interventions, Inc. | Aug 16, 2013 | SESE |
| K031123 | CODMAN BACTISEAL BARIUM STRIPED CATHETERS | Codman & Shurtleff, Inc. | May 14, 2003 | SESE |
| K021481 | BRESAGEN CATHETER, MODEL CS-3000 | Bresagen, Inc. | Aug 6, 2002 | SESE |
| K020728 | MIETHKE SHUNT SYSTEM | Aesculap, Inc. | Apr 5, 2002 | SESE |
| K013005 | ACT 11 MP VENTRICULAR CATHETER | Innerspace, Inc. | Mar 8, 2002 | SESE |
| K003322 | CODMAN BACTISEAL CATHETERS | Codman & Shurtleff, Inc. | Oct 1, 2001 | SESE |
| K992796 | ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000 | Image-Guided Neurologics, Inc. | Oct 25, 1999 | SESE |
| K983331 | MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102 | Medtronic PS Medical | Dec 16, 1998 | SESE |
| K834477 | DISPOS. SCOTT CANNULAS 16-1054 ETC. | Codman & Shurtleff, Inc. | Mar 19, 1984 | SESE |
Top Applicants
- Codman & Shurtleff, Inc. — 3 clearances
- Parker Hannifin Corp. — 1 clearance
- Mri Interventions, Inc. — 1 clearance
- Medtronic PS Medical — 1 clearance
- Innerspace, Inc. — 1 clearance
