Duns Number:008999906
Device Description: The 8F PRONTO XL extraction catheters are indicated for the removal/aspiration of embolic The 8F PRONTO XL extraction catheters are indicated for the removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, the removal/aspiration of embolic material (thrombus/debris) from vessels of the deep venous system and to infuse/deliver diagnostic or therapeutic agents.
Catalog Number
-
Brand Name
Pronto® XL extraction catheter
Version/Model Number
5080
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 02, 2018
Issuing Agency
In HIBCC
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
K112571
Product Code
DXE
Product Code Name
Catheter, Embolectomy
Public Device Record Key
773a7e72-81b5-4928-8670-5215d76c1aca
Public Version Date
August 05, 2022
Public Version Number
5
DI Record Publish Date
September 05, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 238 |
| U | Unclassified | 12 |