• 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, percutaneous
510(k) Number K972978
Device Name VISTA BRITE TIP GUIDING CATHETERS
Applicant
CORDIS CORP.
14201 N.W. 60TH AVE.
miami lakes,  FL  33014
Applicant Contact katherine trevisol
Correspondent
CORDIS CORP.
14201 N.W. 60TH AVE.
miami lakes,  FL  33014
Correspondent Contact katherine trevisol
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/11/1997
Decision Date 10/21/1997
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
-
-