Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Catheter For Crossing Total Occlusions
510(k) Number K230159
Device Name SoundBite® Crossing System XS Peripheral
Applicant
Soundbite Medical Solutions, Inc.
2300 Alfred Nobel, Suite 230
Montreal,  CA H4S 2A4
Applicant Contact Diane Marceau
Correspondent
Soundbite Medical Solutions, Inc.
2300 Alfred Nobel, Suite 230
Montreal,  CA H4S 2A4
Correspondent Contact Diane Marceau
Regulation Number870.1250
Classification Product Code
PDU  
Date Received01/19/2023
Decision Date 08/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-