Duns Number:208993667
Device Description: The SoundBite® Active Wire 14P which is part of the SoundBite® Crossing System - Peripher The SoundBite® Active Wire 14P which is part of the SoundBite® Crossing System - Peripheral (14P) is supplied sterile, has a maximum outer diameter of 0.014” in its usable length (145 cm) and is 300 cm long. Only the distal 145 cm of the SoundBite® Active Wire 14P is ever in contact with patient vasculature. At the proximal end of the SoundBite® Active Wire 14P, a section reducer allows the wire to be connected to the SoundBite® Console.
Catalog Number
-
Brand Name
SoundBite® Active Wire 14P
Version/Model Number
900-0001885
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 30, 2021
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
K210839,K210839
Product Code
PDU
Product Code Name
Catheter For Crossing Total Occlusions
Public Device Record Key
2d027581-2ac5-4cf7-9e19-6f958cd073a7
Public Version Date
December 22, 2021
Public Version Number
4
DI Record Publish Date
April 30, 2021
Package DI Number
20754026501020
Quantity per Package
1
Contains DI Package
10754026501023
Package Discontinue Date
June 30, 2021
Package Status
Not in Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |