NDQ · System, Catheter Or Guidewire, Steerable (Magnetic)
Cardiovascular · 21 CFR 870.1290 · Class 2
Overview
| Product Code | NDQ |
|---|---|
| Device Name | System, Catheter Or Guidewire, Steerable (Magnetic) |
| Regulation | 21 CFR 870.1290 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K060967 | NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION | Stereotaxis, Inc. | Oct 19, 2006 | SESE |
| K051373 | CRONUS GUIDEWIRE, MODEL 001-001470-1 | Stereotaxis, Inc. | Dec 9, 2005 | SESE |
Top Applicants
- Stereotaxis, Inc. — 2 clearances
