HCA — Catheter, Ventricular Class II
FDA product code HCA covers "Catheter, Ventricular", a Class II medical device regulated under 21 CFR 882.4100. Submissions are reviewed by the Neurology panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HCA
- Device Class
- Class II
- Regulation Number
- 882.4100
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K161731 | parker hannifin | Cleveland Multiport Ventricular Catheter Set | March 27, 2017 |
| K123605 | mri interventions | SMARTFLOW CATHETER | August 16, 2013 |
| K031123 | codman and shurtleff | CODMAN BACTISEAL BARIUM STRIPED CATHETERS | May 14, 2003 |
| K021481 | bresagen | BRESAGEN CATHETER, MODEL CS-3000 | August 6, 2002 |
| K020728 | aesculap | MIETHKE SHUNT SYSTEM | April 5, 2002 |
| K013005 | innerspace | ACT 11 MP VENTRICULAR CATHETER | March 8, 2002 |
| K003322 | codman and shurtleff | CODMAN BACTISEAL CATHETERS | October 1, 2001 |
| K992796 | image-guided neurologics | ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000 | October 25, 1999 |
| K983331 | medtronic ps medical | MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102 | December 16, 1998 |
| K834477 | codman and shurtleff | DISPOS. SCOTT CANNULAS 16-1054 ETC. | March 19, 1984 |