Duns Number:025984823
Device Description: IMPEDE Embolization Plug 7mm
Catalog Number
IMP-07
Brand Name
IMPEDE Embolization Plug
Version/Model Number
IMP-07
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 12, 2021
Issuing Agency
In HIBCC
MRI safety Status
MR Conditional
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
K181051
Product Code
KRD
Product Code Name
Device, Vascular, For Promoting Embolization
Public Device Record Key
33febc94-accb-4516-9d57-517af29d63c6
Public Version Date
April 08, 2022
Public Version Number
4
DI Record Publish Date
October 31, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 12 |