FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
EasyMap MAP Catheter
K Number: K151139
·
Decision Oct 18, 2016
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
184
Applicant Total
1
Review Days
538
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EasyMap MAP Catheter
- K Number
- K151139
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1220
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medfact Engineering GmbH
- Date Received
- April 29, 2015
- Decision Date
- October 18, 2016
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRF), ordered by most recent decision date.
Vision-MR Diagnostic Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
MAGiC Sweep EP Mapping Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
VIKING Fixed Curve Diagnostic Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional Steerable Diagnostic Catheter; Dynamic XT Unidirectional Steerable Diagnostic Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Nordica PV Cryo Mapping Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Cosine-10TM Diagnostic Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular