Duns Number:024942265
Device Description: "Genesis MNS is intended to navigate compatible magnetic devices through tissue to designa "Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right andleft heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desireddirection. "
Catalog Number
001-011000-3
Brand Name
Genesis MNS with Model-S
Version/Model Number
1.1 Model-S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K193147
Product Code
NDQ
Product Code Name
System, Catheter Or Guidewire, Steerable (Magnetic)
Public Device Record Key
888c8dad-7934-4641-810e-6a929b829ae8
Public Version Date
August 28, 2020
Public Version Number
1
DI Record Publish Date
August 20, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |