Duns Number:006261481
Device Description: ATHERECTOMY P4028 DS SILVERHAWK BTK UNI
Catalog Number
-
Brand Name
SilverHawk™
Version/Model Number
P4028
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
K170191
Product Code
MCW
Product Code Name
Catheter, peripheral, atherectomy
Public Device Record Key
7d815837-27ac-4d52-aae1-5f9e4419a93e
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
April 22, 2018
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 |