FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Hansen Medical Magellan Robotic Catheter 9Fr
K Number: K160919
·
Decision Sep 20, 2016
Classifications
1
FEI Numbers
46
Registration Numbers
47
Same Product Code
40
Applicant Total
14
Review Days
169
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Hansen Medical Magellan Robotic Catheter 9Fr
- K Number
- K160919
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1280
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hansen Medical, Inc.
- Date Received
- April 4, 2016
- Decision Date
- September 20, 2016
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRA), ordered by most recent decision date.
Globe Introducer (601-01001)
FDA 510(k)
FDA Class 2
·Cardiovascular
FARADRIVE Steerable Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
FlexCath Contour Steerable Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
POLARSHEATH Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE Pressure Sensor
FDA 510(k)
FDA Class 2
·Cardiovascular
MitraClip G4 Steerable Guide Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
AcQGuide® VUE Steerable Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Hansen Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K082075 | HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER | Aug 15, 2008 | Substantially Equivalent |