HCA
10 FDA 510(k) clearances · Product code
90 daysmedian time to decision
342 days90th percentile
10clearances measured
FDA profile
- Official device name
- Catheter, Ventricular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4100
- Medical specialty
- Neurology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2005: 5 · 2006: 8 · 2007: 8 · 2008: 3 · 2010: 4 · 2011: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Cleveland Multiport Ventricular Catheter Set (K161731) | Parker Hannifin Corp. | 2017-03-27 |
| SMARTFLOW CATHETER (K123605) | Mri Interventions, Inc. | 2013-08-16 |
| CODMAN BACTISEAL BARIUM STRIPED CATHETERS (K031123) | Codman & Shurtleff, Inc. | 2003-05-14 |
| BRESAGEN CATHETER, MODEL CS-3000 (K021481) | Bresagen, Inc. | 2002-08-06 |
| MIETHKE SHUNT SYSTEM (K020728) | Aesculap, Inc. | 2002-04-05 |
| ACT 11 MP VENTRICULAR CATHETER (K013005) | Innerspace, Inc. | 2002-03-08 |
| CODMAN BACTISEAL CATHETERS (K003322) | Codman & Shurtleff, Inc. | 2001-10-01 |
| ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000 (K992796) | Image-Guided Neurologics, Inc. | 1999-10-25 |
| MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102 (K983331) | Medtronic PS Medical | 1998-12-16 |
| DISPOS. SCOTT CANNULAS 16-1054 ETC. (K834477) | Codman & Shurtleff, Inc. | 1984-03-19 |
Track HCA automatically
Every clearance here is in the API, with alerts when new ones post.