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, therapeutic, short-term less than 30 days
510(k) Number K861479
Device Name CAVAFIX, CENTRAL VENOUS CATHETER KIT
Applicant
BURRON MEDICAL PRODUCTS, INC.
824 TWELFTH AVE.
BETHLEHEM,  PA  18018
Applicant Contact TRACEY YAKABOW
Correspondent
BURRON MEDICAL PRODUCTS, INC.
824 TWELFTH AVE.
BETHLEHEM,  PA  18018
Correspondent Contact TRACEY YAKABOW
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received04/22/1986
Decision Date 07/01/1986
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
-
-