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, Angioplasty, Peripheral, Transluminal
510(k) Number K152665
Device Name PolarCath Peripheral Dilatation System
Applicant
Nucyro Vascular, LLC
746 San Aleso Ave.
Sunnyvale,  CA  94085
Applicant Contact MIKE FOURKAS
Correspondent
Experien Group, LLC
755 N Mathilda Ave.
Suite 100
Sunnyvale,  CA  94085
Correspondent Contact MICHAEL BILLIG
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received09/17/2015
Decision Date 10/26/2015
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
Recalls CDRH Recalls
-
-