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 Wire, Guide, Catheter
510(k) Number K180177
Device Name Guidewire
Applicant
Shanghai Kindly Medical Instruments Co.,Ltd
#925, Jinyuan Yi Rd.
Shanghai,  CN 201803
Applicant Contact Xu Jianhai
Correspondent
Shanghai Kindly Medical Instruments Co.,Ltd
#925, Jinyuan Yi Rd.
Shanghai,  CN 201803
Correspondent Contact Jeffery Hui
Regulation Number870.1330
Classification Product Code
DQX  
Date Received01/22/2018
Decision Date 09/13/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-