FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH
K Number: K052480
·
Decision May 2, 2007
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
32
Applicant Total
14
Review Days
600
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Basic Information
- Device Name
- HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH
- K Number
- K052480
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1290
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Hansen Medical, Inc.
- Date Received
- September 9, 2005
- Decision Date
- May 2, 2007
- 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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|---|---|---|---|
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| K151463 | Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components | Aug 18, 2015 | Substantially Equivalent |
| K151730 | Magellan Robotic System | Jul 23, 2015 | Substantially Equivalent |
| K143227 | Magellan Robotic System, Magellan Robotic Catheter 10Fr | Jul 1, 2015 | Substantially Equivalent |
| K132369 | MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR | Sep 27, 2013 | Substantially Equivalent |
| K111004 | HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER | May 29, 2012 | Substantially Equivalent |
| K102168 | SENSEI X ROBOTIC CATHETER SYSTEM | Oct 22, 2010 | Substantially Equivalent |
| K091808 | SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 | Sep 10, 2009 | Unknown |
| K090365 | HANSEN MEDICAL ARTISAN S CONTROL CATHETER | May 7, 2009 | Unknown |