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 Percutaneous Catheter, Ultrasound
510(k) Number K191840
Device Name Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)
Applicant
Shockwave Medical, Inc.
5403 Betsy Ross Dr.
Santa Clara,  CA  95054
Applicant Contact Cindy Morrow
Correspondent
Shockwave Medical, Inc.
5403 Betsy Ross Dr.
Santa Clara,  CA  95054
Correspondent Contact Cindy Morrow
Regulation Number870.1250
Classification Product Code
PPN  
Date Received07/09/2019
Decision Date 08/07/2019
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
-
-