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, Ultrasound, Intravascular
510(k) Number K240050
Device Name SOUNDSTAR™ CRYSTAL Ultrasound Catheter
Applicant
Biosense Webster, Inc.
(Part Of Johnson&Johnson Family Of Companies)
31 Technology Dr., Suite 200
Irvine,  CA  92618
Applicant Contact Sheba Chacko
Correspondent
Biosense Webster, Inc.
(Part Of Johnson&Johnson Family Of Companies)
31 Technology Dr., Suite 200
Irvine,  CA  92618
Correspondent Contact Sheba Chacko
Regulation Number870.1200
Classification Product Code
OBJ  
Date Received01/08/2024
Decision Date 06/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-