Duns Number:592534619
Device Description: The Antegrade Femoral Access Platform is designed to assist in supporting equipment during The Antegrade Femoral Access Platform is designed to assist in supporting equipment during the antegrade approach to the femoral artery
Catalog Number
AM0440
Brand Name
Adept Medical Antegrade IR Platform
Version/Model Number
AM0440
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KMN
Product Code Name
Chair And Table, Medical
Public Device Record Key
b6bb6889-8ba2-443c-b224-6225a9474ae9
Public Version Date
July 05, 2019
Public Version Number
1
DI Record Publish Date
June 27, 2019
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 33 |