FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR
K Number: K061070
·
Decision Oct 13, 2006
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
50
Applicant Total
14
Review Days
179
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Basic Information
- Device Name
- HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR
- K Number
- K061070
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1390
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hansen Medical, Inc.
- Date Received
- April 17, 2006
- Decision Date
- October 13, 2006
- Product Code
- DRC
- 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 |
|---|---|---|---|
| DRC | Trocar | FDA class 2 | Cardiovascular |
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|---|---|---|---|
| K160919 | Hansen Medical Magellan Robotic Catheter 9Fr | Sep 20, 2016 | Substantially Equivalent |
| K153304 | Hansen Medical Magellan Robotic Catheter eKit | Feb 1, 2016 | Substantially Equivalent |
| 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 |