FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT
K Number: K133552
·
Decision Feb 7, 2014
Classifications
1
FEI Numbers
46
Registration Numbers
47
Same Product Code
40
Applicant Total
3
Review Days
80
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Basic Information
- Device Name
- MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT
- K Number
- K133552
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1280
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hansen Medical
- Date Received
- November 19, 2013
- Decision Date
- February 7, 2014
- Product Code
- DRA
- 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 |
|---|---|---|---|
| DRA | Catheter, Steerable | FDA class 2 | Cardiovascular |
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