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 K921270
Device Name SAFE-DWELL PLUS CENTRAL VENOUS CATHETER
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
9450 S. State Sreet
Sandy,  UT  84070
Applicant Contact CHARLES J WELLE
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
9450 S. State Sreet
Sandy,  UT  84070
Correspondent Contact CHARLES J WELLE
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received03/17/1992
Decision Date 09/28/1992
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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
-
-