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, Intravascular, Diagnostic
510(k) Number K041291
Device Name RINSPIRATION SYSTEM
Applicant
Kerberos Proximal Solutions, Inc.
1400 Terra Bella Ave., Suite K
Mountain View,  CA  94043
Applicant Contact TOM MASON
Correspondent
Kerberos Proximal Solutions, Inc.
1400 Terra Bella Ave., Suite K
Mountain View,  CA  94043
Correspondent Contact TOM MASON
Regulation Number870.1200
Classification Product Code
DQO  
Date Received05/14/2004
Decision Date 05/21/2004
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
-
-