FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IntellaMap Orion High Resolution Mapping Catheter
K Number: K143481
·
Decision Jan 8, 2015
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
184
Applicant Total
3
Review Days
31
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Basic Information
- Device Name
- IntellaMap Orion High Resolution Mapping Catheter
- K Number
- K143481
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1220
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rhythmia Medical, Inc.
- Date Received
- December 8, 2014
- Decision Date
- January 8, 2015
- 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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