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 K001795
Device Name THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD
Applicant
Avitro, LLC
2200 Lake Shore Dr.
Woodstock,  IL  60098
Applicant Contact JOHN BRDA
Correspondent
Avitro, LLC
2200 Lake Shore Dr.
Woodstock,  IL  60098
Correspondent Contact JOHN BRDA
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received06/14/2000
Decision Date 10/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-