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 K032292
Device Name BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX
Applicant
BIOTEQUE CORP.
3892 SOUTH AMERICA WEST TRAIL
FLAGGSTAFF,  AZ  86001
Applicant Contact JENNIFER REICH
Correspondent
BIOTEQUE CORP.
3892 SOUTH AMERICA WEST TRAIL
FLAGGSTAFF,  AZ  86001
Correspondent Contact JENNIFER REICH
Regulation Number880.5200
Classification Product Code
FOZ  
Subsequent Product Code
FIE  
Date Received07/24/2003
Decision Date 03/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-