Duns Number:101835833
Device Description: Hemostatic Peel Away Introducer System with Infusion Sideport, 13 cm and 25 cm
Catalog Number
0052-3025
Brand Name
Introducer Kit for Impella®
Version/Model Number
0052-3025
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
K122084
Product Code
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
4196a348-981a-4b0b-bfce-129b32b9900d
Public Version Date
June 07, 2019
Public Version Number
4
DI Record Publish Date
November 30, 2017
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. | 592 |
| 3 | A medical device with high risk that requires premarket approval | 16 |