Duns Number:006261481
Device Description: ATHERECTOMY THP-S TH PLUS 6F US
Catalog Number
-
Brand Name
TurboHawk™ Plus
Version/Model Number
THP-S
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
K212027
Product Code
MCW
Product Code Name
Catheter, peripheral, atherectomy
Public Device Record Key
2a4491fe-4500-4025-9d6a-ca118fb9e20f
Public Version Date
October 04, 2021
Public Version Number
1
DI Record Publish Date
September 26, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |