Duns Number:015575953
Device Description: Polaris X Steerable Diagnostic EP Catheter 105 cm Standard Curve 10 Electrodes 2.5-5-2.5 m Polaris X Steerable Diagnostic EP Catheter 105 cm Standard Curve 10 Electrodes 2.5-5-2.5 mm Spacing 6F
Catalog Number
7003D
Brand Name
N/A
Version/Model Number
N/A
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
Yes
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
K160303
Product Code
NLH
Product Code Name
Catheter, Recording, Electrode, Reprocessed
Public Device Record Key
22aec83d-d6ff-4034-a455-2c7dfef444c1
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 23, 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. | 684 |