Duns Number:151047370
Device Description: Turbo-Elite™ Laser Atherectomy Catheter
Catalog Number
425-135-01
Brand Name
Turbo Elite™
Version/Model Number
425-135-01AA
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
-
Product Code
MCW
Product Code Name
Catheter, Peripheral, Atherectomy
Public Device Record Key
aefe7163-a339-4487-bc50-e15994d5d36a
Public Version Date
October 26, 2021
Public Version Number
3
DI Record Publish Date
February 06, 2015
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. | 251 |
3 | A medical device with high risk that requires premarket approval | 126 |