Duns Number:002348191
Device Description: Pronto V4, 7F
Catalog Number
4007
Brand Name
PRONTO
Version/Model Number
IPN913532
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
K103405,K103405
Product Code
DXE
Product Code Name
Catheter, embolectomy
Public Device Record Key
90b746b6-c226-449e-80cf-eb2b894919ab
Public Version Date
August 05, 2022
Public Version Number
2
DI Record Publish Date
November 08, 2018
Package DI Number
30841156100241
Quantity per Package
1
Contains DI Package
10841156100247
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |