• 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 adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
510(k) Number K991102
Device Name COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331
Applicant
GUIDANT CORP.
26531 YNEZ RD.
temecula,  CA  92591 -4630
Applicant Contact stacey simon
Correspondent
GUIDANT CORP.
26531 YNEZ RD.
temecula,  CA  92591 -4630
Correspondent Contact stacey simon
Regulation Number870.4290
Classification Product Code
DTL  
Date Received04/01/1999
Decision Date 06/09/1999
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-