FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Hansen Medical Magellan Robotic Catheter eKit
K Number: K153304
·
Decision Feb 1, 2016
Classifications
1
FEI Numbers
41
Registration Numbers
42
Same Product Code
40
Applicant Total
1
Review Days
77
Basic Information
- Device Name
- Hansen Medical Magellan Robotic Catheter eKit
- K Number
- K153304
- 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
- November 16, 2015
- Decision Date
- February 1, 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