• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name catheter, intravascular, diagnostic
510(k) Number K041123
Device Name RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG01477/FG01703
Original Applicant
KERBEROS PROXIMAL SOLUTIONS, INC.
1400 terra bella ave, suite k
mountain view,  CA  94043
Original Contact tom mason
Regulation Number870.1200
Classification Product Code
DQO  
Date Received04/30/2004
Decision Date 08/26/2004
Decision se - with limitations (SESU)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-