Duns Number:098414659
Device Description: The Surmodics™ Pounce™ Thrombus Retrieval System is a percutaneous catheter system designe The Surmodics™ Pounce™ Thrombus Retrieval System is a percutaneous catheter system designed to facilitate mechanical thrombus removal in the arterial peripheral vasculature.
Catalog Number
-
Brand Name
Pounce™ Thrombectomy System
Version/Model Number
PTS-0607-7F135
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
K192814
Product Code
QEW
Product Code Name
Peripheral Mechanical Thrombectomy With Aspiration
Public Device Record Key
5af58768-490d-4207-93e0-2b3ab5331f2c
Public Version Date
August 05, 2022
Public Version Number
2
DI Record Publish Date
December 27, 2021
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. | 2 |