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 K201775
Device Name NuVision ICE Catheter
Applicant
NuVera Medical, Inc.
140 Knowles Dr.
Los Gatos,  CA  95032
Applicant Contact Robert Nardelli
Correspondent
NuVera Medical, Inc.
140 Knowles Dr.
Los Gatos,  CA  95032
Correspondent Contact Robert Nardelli
Regulation Number870.1200
Classification Product Code
OBJ  
Date Received06/29/2020
Decision Date 03/05/2021
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
-
-