Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components
FDA 510(k) clearance K151463 · decided 2015-08-18
Clearance details
- K-number
- K151463
- Device name
- Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components
- Applicant
- Hansen Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-06-01
- Decision date
- 2015-08-18
- Days to decision
- 78 days
- Clearance type
- Special
- Product code
- DRA
- Device class
- 2
- Regulation number
- 870.1280
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.