• 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 K213085
Device Name Introcan Safety 3 Closed IV Catheter
B.Braun Medical Inc.
901 Marcon Blvd
Allentown,  PA  18109
Applicant Contact Tracy Larish
B.Braun Medical Inc.
901 Marcon Blvd
Allentown,  PA  18109
Correspondent Contact Tracy Larish
Regulation Number880.5200
Classification Product Code
Date Received09/24/2021
Decision Date 10/25/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No