Duns Number:006133784
Device Description: Surgical Ablation System Open, Long Jaw with Glidepath Magnetic Guide
Catalog Number
A001143
Brand Name
AtriCure Isolator Synergy EnCompass Clamp and Guide System
Version/Model Number
OLH
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"
Yes
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
K210477,K210477,K210477
Product Code
OCL
Product Code Name
Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Public Device Record Key
7638a44d-f9f7-400a-86db-4effaf575673
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
July 29, 2021
Package DI Number
30840143903353
Quantity per Package
1
Contains DI Package
10840143904110
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 129 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 133 |
| 3 | A medical device with high risk that requires premarket approval | 11 |