Duns Number:413819707
Device Description: Software medical device, used with a Philips Interventional X-Ray System. Assists the user Software medical device, used with a Philips Interventional X-Ray System. Assists the user with treatment of structural heart diseases using minimal invasive interventional techniques.
Catalog Number
001001
Brand Name
HeartNavigator
Version/Model Number
HeartNavigator - 2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K140138
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
998f9b67-876d-482c-81e5-383457242da6
Public Version Date
November 13, 2020
Public Version Number
7
DI Record Publish Date
September 24, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 349 |