FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
AMIGO REMOTE CATHETER SYSTEM
K Number: DEN140009
·
Decision Dec 18, 2014
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
3
Applicant Total
3
Review Days
303
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Basic Information
- Device Name
- AMIGO REMOTE CATHETER SYSTEM
- K Number
- DEN140009
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 870.5700
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Applicant
- Catheter Robotics, Inc.
- Date Received
- February 18, 2014
- Decision Date
- December 18, 2014
- Product Code
- PJB
- 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 |
|---|---|---|---|
| PJB | Catheter Remote Control System | FDA class 2 | Cardiovascular |
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