FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
HORIZON XVU (FFR)
K Number: K123792
·
Decision Aug 30, 2013
Classifications
1
FEI Numbers
252
Registration Numbers
253
Same Product Code
751
Applicant Total
21
Review Days
263
Basic Information
- Device Name
- HORIZON XVU (FFR)
- K Number
- K123792
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MENNEN MEDICAL LTD.
- Date Received
- December 10, 2012
- Decision Date
- August 30, 2013
- Product Code
- DQX
- 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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | FDA class 2 | Cardiovascular |
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