FDA Product Code
FDA Product Code HCA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.4100
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K161731 | Cleveland Multiport Ventricular Catheter Set | Parker Hannifin Corp. | 2017-03-27 | Traditional | PDF ↗ |
| K123605 | SMARTFLOW CATHETER | Mri Interventions, Inc. | 2013-08-16 | Traditional | PDF ↗ |
| K031123 | CODMAN BACTISEAL BARIUM STRIPED CATHETERS | Codman & Shurtleff, Inc. | 2003-05-14 | Special | PDF ↗ |
| K021481 | BRESAGEN CATHETER, MODEL CS-3000 | Bresagen, Inc. | 2002-08-06 | Traditional | PDF ↗ |
| K020728 | MIETHKE SHUNT SYSTEM | Aesculap, Inc. | 2002-04-05 | Special | PDF ↗ |
| K013005 | ACT 11 MP VENTRICULAR CATHETER | Innerspace, Inc. | 2002-03-08 | Traditional | PDF ↗ |
| K003322 | CODMAN BACTISEAL CATHETERS | Codman & Shurtleff, Inc. | 2001-10-01 | Traditional | PDF ↗ |
| K992796 | ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000 | Image-Guided Neurologics, Inc. | 1999-10-25 | Traditional | PDF ↗ |
| K983331 | MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102 | Medtronic PS Medical | 1998-12-16 | Traditional | PDF ↗ |
| K834477 | DISPOS. SCOTT CANNULAS 16-1054 ETC. | Codman & Shurtleff, Inc. | 1984-03-19 | Traditional | PDF ↗ |
Product code HCA · Class II · Neurology. Data: openFDA.