• 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 K202060
Device Name Disposable IV catheter
Shinva Ande Healthcare Apparatus Co., Ltd.
No.77 Development Zone North Road
Zibo,  CN 255086
Applicant Contact Liang Wanjie
Beijing Believe-Med Technology Service Co.,Ltd
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd.
FangShan District,  CN 102401
Correspondent Contact Ray Wang
Regulation Number880.5200
Classification Product Code
Date Received07/27/2020
Decision Date 07/23/2021
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