Duns Number:826110710
Device Description: STENT SFR3-4-20-10 V06 ENHANCED
Catalog Number
-
Brand Name
Solitaire™ Platinum
Version/Model Number
SFR3-4-20-10
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
K181186
Product Code
NRY
Product Code Name
CATHETER, THROMBUS RETRIEVER
Public Device Record Key
8c6ee332-7275-402c-853e-b3fb5bf8d6c8
Public Version Date
August 05, 2022
Public Version Number
2
DI Record Publish Date
March 15, 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. | 1759 |
3 | A medical device with high risk that requires premarket approval | 562 |