Catheter, Ventricular
FDA product code HCA · Class II (moderate risk) · 21 CFR 882.4100 · Neurology
10510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K161731 | Cleveland Multiport Ventricular Catheter SetHCA · Traditional | Parker Hannifin Corp. | 03/27/2017SE |
| K123605 | Smartflow CatheterHCA · Traditional | Mri Interventions, Inc. | 08/16/2013SE |
| K031123 | Codman Bactiseal Barium Striped CathetersHCA · Special | Codman & Shurtleff, Inc. | 05/14/2003SE |
| K021481 | Bresagen Catheter, Model CS-3000HCA · Traditional | Bresagen, Inc. | 08/06/2002SE |
| K020728 | Miethke Shunt SystemHCA · Special | Aesculap, Inc. | 04/05/2002SE |
| K013005 | Act 11 MP Ventricular CatheterHCA · Traditional | Innerspace, Inc. | 03/08/2002SE |
| K003322 | Codman Bactiseal CathetersHCA · Traditional | Codman & Shurtleff, Inc. | 10/01/2001SE |
| K992796 | Aspiration/Irrigation Catheter, Model AC-1000HCA · Traditional | Image-Guided Neurologics, Inc. | 10/25/1999SE |
| K983331 | Medtronic PS Medical Innervision Ventricular Catheter, 15CM Model 99102HCA · Traditional | Medtronic PS Medical | 12/16/1998SE |
| K834477 | Dispos. Scott Cannulas 16-1054 Etc.HCA · Traditional | Codman & Shurtleff, Inc. | 03/19/1984SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1354-2021 Class II | CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm…Incorrect labeling, Catheter did not have the required holes and markings | Integra LifeSciences Corp. | 03/17/2021Terminated |