Duns Number:608625823
Device Description: The device is the Phillips 0.9mm OTW Turbo Elite Laser Atherectomy catheter that is reproc The device is the Phillips 0.9mm OTW Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NES).
Catalog Number
R-410-152
Brand Name
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter
Version/Model Number
R-410-152
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K220171
Product Code
QTF
Product Code Name
Reprocessed Atherectomy Catheter
Public Device Record Key
12704b0e-81f8-46e8-89d5-8581ca968852
Public Version Date
August 30, 2022
Public Version Number
1
DI Record Publish Date
August 22, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |