Duns Number:050636737
Catalog Number
0052-3069
Brand Name
Impella® 23F x 30cm Sheath
Version/Model Number
ABMD 23Fr X 30cm Introducer Kit
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K201116
Product Code
DYB
Product Code Name
Introducer, Catheter
Public Device Record Key
beaa920a-7f2b-48f9-9f65-afad074bda7a
Public Version Date
July 28, 2020
Public Version Number
1
DI Record Publish Date
July 20, 2020
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. | 16 |
3 | A medical device with high risk that requires premarket approval | 47 |