Duns Number:968903703
Device Description: Peripheral Plaque Excision System;Large Vessel Standard Tip with MEC TechNlogy
Catalog Number
P4052
Brand Name
SilverHawk
Version/Model Number
P4052
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
7b25ac0a-2e85-49cf-a533-2dcfab3fa79b
Public Version Date
April 17, 2018
Public Version Number
3
DI Record Publish Date
October 12, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |