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 introducer, catheter
510(k) Number K193125
Device Name R2P Destination Slender Guiding Sheath
Applicant
Terumo Medical Corporation
950 Elkton Blvd.
Elkton,  MD  21921
Applicant Contact Liang Lu
Correspondent
Terumo Medical Corporation
950 Elkton Blvd.
Elkton,  MD  21921
Correspondent Contact Liang Lu
Regulation Number870.1340
Classification Product Code
DYB  
Date Received11/12/2019
Decision Date 01/06/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-