Duns Number:149818952
Device Description: Multi-electrode Diagnostic Catheter
Catalog Number
EC1000
Brand Name
EnSite™
Version/Model Number
EC1000
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
K121006,K121006
Product Code
MTD
Product Code Name
CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
Public Device Record Key
b158aae5-89c2-4ded-9e1b-ccc828ec2f12
Public Version Date
February 25, 2021
Public Version Number
5
DI Record Publish Date
May 03, 2016
Package DI Number
15414734215661
Quantity per Package
5
Contains DI Package
05414734215664
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 70 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1429 |
| 3 | A medical device with high risk that requires premarket approval | 736 |