FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAGiC Sweep EP Mapping Catheter
K Number: K250590
·
Decision Jul 23, 2025
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
184
Applicant Total
28
Review Days
146
Basic Information
- Device Name
- MAGiC Sweep EP Mapping Catheter
- K Number
- K250590
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1220
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stereotaxis, Inc.
- Date Received
- February 27, 2025
- Decision Date
- July 23, 2025
- Product Code
- DRF
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K150312 | Vdrive system, Vdrive Duo, Vdrive with V-Sono | Jun 17, 2015 | Substantially Equivalent |
| K141530 | VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS | Dec 18, 2014 | Substantially Equivalent |
| K140804 | VDRIVE WITH V-LOOP/ VDRIVE DUO | Sep 3, 2014 | Substantially Equivalent |
| K133396 | VDRIVE WITH V-SONO | Feb 6, 2014 | Substantially Equivalent |
| K122659 | VDRIVE W/V-SONO | Jul 26, 2013 | Substantially Equivalent |