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, Peripheral, Atherectomy
510(k) Number K241553
Device Name Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating
Applicant
Eximo Medical, Ltd.
Pekeris St. 3
Rehovot,  IL 7670203
Applicant Contact Yoel Zabar
Correspondent
AngioDynamics, Inc.
603 Queensbury Ave.
Queensburgy,  NY  12804
Correspondent Contact Kasey Newcomb
Regulation Number870.4875
Classification Product Code
MCW  
Date Received05/31/2024
Decision Date 06/27/2024
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
Recalls CDRH Recalls
-
-