Duns Number:131489882
Device Description: SOLOPATH Balloon Expandable TransFemoral System
Catalog Number
STFI-1425
Brand Name
SOLOPATH
Version/Model Number
STFI-1425
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 15, 2019
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
-
Product Code
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
bcb77ad3-84d0-4f06-8e33-8ddffdee34fc
Public Version Date
March 12, 2020
Public Version Number
3
DI Record Publish Date
May 17, 2018
Package DI Number
50389701012136
Quantity per Package
39
Contains DI Package
00389701012131
Package Discontinue Date
November 15, 2019
Package Status
Not in Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 142 |
| 3 | A medical device with high risk that requires premarket approval | 4 |