CRONUS GUIDEWIRE, MODEL 001-001470-1
FDA 510(k) clearance K051373 · decided 2005-12-09
Clearance details
- K-number
- K051373
- Device name
- CRONUS GUIDEWIRE, MODEL 001-001470-1
- Applicant
- Stereotaxis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-05-26
- Decision date
- 2005-12-09
- Days to decision
- 197 days
- Clearance type
- Traditional
- Product code
- NDQ
- Device class
- 2
- Regulation number
- 870.1290
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Saint Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION (K060967) | Stereotaxis, Inc. | 2006-10-19 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HELIOS II ABLATION CATHETER (P050029) | Stereotaxis, Inc. | 2008-10-10 |