Duns Number:208993667
Device Description: The SoundBite® Console generates controlled high-amplitude short-duration mechanical pulse The SoundBite® Console generates controlled high-amplitude short-duration mechanical pulses (i.e., shock waves) which are transmitted to a connected SoundBite® Active Wire 14P and cause the distal tip of the active wire to move back and forth (axially), acting like a micro-jackhammer. After the passage of each pulse, the tip goes back to its original position.
Catalog Number
-
Brand Name
SoundBite® Console
Version/Model Number
9AB-C001091
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
-
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
Product Code
PDU
Product Code Name
Catheter For Crossing Total Occlusions
Public Device Record Key
a188048a-8e53-479c-8b7b-c43d3928d692
Public Version Date
June 30, 2021
Public Version Number
3
DI Record Publish Date
April 30, 2021
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. | 3 |