• 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, retention type, balloon
510(k) Number K182635
Device Name Signal Catheter
Safe Medical Design
2722 Fulton Street
San Francisco,  CA  94118
Applicant Contact Raymond "Buzz" Bonneau
AcKnowledge Regulatory Strategies, LLC
2251 San Diego Avenue, Suite B-257
San Diego,  CA  92110
Correspondent Contact Allison Komiyama
Regulation Number876.5130
Classification Product Code
Date Received09/24/2018
Decision Date 01/10/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No