• 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, therapeutic, short-term less than 30 days
510(k) Number K890435
Device Name VITAACCESS CATHETER INTRODUCER KIT
Applicant
VITAPHORE CORP.
887 INDUSTRIAL RD.
SAN CARLOS,  CA  94070
Applicant Contact JESSICA AYRES
Correspondent
VITAPHORE CORP.
887 INDUSTRIAL RD.
SAN CARLOS,  CA  94070
Correspondent Contact JESSICA AYRES
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received01/27/1989
Decision Date 03/29/1989
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-