Duns Number:076827459
Device Description: ClotTriever BOLD Catheter (ClotTriever Thrombectomy System)
Catalog Number
-
Brand Name
ClotTriever BOLD Catheter
Version/Model Number
42-102
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
K212632
Product Code
QEW
Product Code Name
Peripheral Mechanical Thrombectomy With Aspiration
Public Device Record Key
7e21468c-83d9-414d-b758-9f5a0dc4628e
Public Version Date
August 05, 2022
Public Version Number
2
DI Record Publish Date
June 15, 2022
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |