FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES
K Number: K113628
·
Decision Jun 12, 2012
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
32
Applicant Total
3
Review Days
187
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Basic Information
- Device Name
- AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES
- K Number
- K113628
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1290
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Catheter Robotics, Inc.
- Date Received
- December 8, 2011
- Decision Date
- June 12, 2012
- Product Code
- DXX
- 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 |
|---|---|---|---|
| DXX | System, Catheter Control, Steerable | FDA class 2 | Cardiovascular |
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