510(k) K051373
- Device
- CRONUS GUIDEWIRE, MODEL 001-001470-1
- Applicant
- STEREOTAXIS, INC.
- 510(k) number
- K051373
- Product code
- NDQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-12-09
- Date received
- 2005-05-26
- Regulation
- 870.1290
- Classification name
- System, Catheter Or Guidewire, Steerable (magnetic)
- Medical specialty
- Cardiovascular
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KELLY ROWLAND
- Address
- 4041 Forest Park Ave. Saint Louis MO US 63108 63108
FDA Registration Numbers#
- 3003084417
Source Documents#
Other 510(k) Records For Product Code NDQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K060967 | NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION | Stereotaxis, Inc. | 2006-10-19 |
Legacy Summary#
summary
FDA Review#
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