• 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, tracheal (w/wo connector)
510(k) Number K172208
Device Name NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet
NeVap, Inc.
975 Dionne Way
San Jose,  CA  95133
Applicant Contact Brenton Hanlon
MAE Consulting Group, LLC
119 North Road
Deerfield,  NH  03037
Correspondent Contact Janet Kwiatkowski
Regulation Number868.5730
Classification Product Code
Subsequent Product Code
Date Received07/24/2017
Decision Date 02/16/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No