FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER
K Number: K082075
·
Decision Aug 15, 2008
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
103
Applicant Total
14
Review Days
23
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Basic Information
- Device Name
- HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER
- K Number
- K082075
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hansen Medical, Inc.
- Date Received
- July 23, 2008
- Decision Date
- August 15, 2008
- Product Code
- DRE
- 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 |
|---|---|---|---|
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 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 |
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| 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 |