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 tube tracheostomy and tube cuff
510(k) Number K193077
Device Name Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff
Applicant
Covidien
6135 Gunbarrel Ave
Boulder,  CO  80301
Applicant Contact Stacy Barton
Correspondent
Covidien
6135 Gunbarrel Ave
Boulder,  CO  80301
Correspondent Contact Stacy Barton
Regulation Number868.5800
Classification Product Code
JOH  
Subsequent Product Code
BTO  
Date Received11/05/2019
Decision Date 06/01/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-