Duns Number:184805166
Device Description: LeMaitre Aortic Occlusion Catheter, 8F, eIFU
Catalog Number
e2107-80
Brand Name
LeMaitre Aortic Occlusion Catheter
Version/Model Number
e2107-80
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)
Yes
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
K132022
Product Code
MJN
Product Code Name
Catheter, Intravascular Occluding, Temporary
Public Device Record Key
1d6184af-7a7b-443b-9c13-d03dfaa4c6da
Public Version Date
April 21, 2021
Public Version Number
5
DI Record Publish Date
June 30, 2015
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 453 |
| 3 | A medical device with high risk that requires premarket approval | 22 |