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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K243579
Device Name AeroJet Ventilation Catheter
Applicant
Pipeline Medical Products, LLC
122 Park Ave.
Weymouth,  MA  02190
Applicant Contact John Morgan
Correspondent
AlvaMed, Inc.
935 Great Plain Ave.
Unit 166
Needham,  MA  02492
Correspondent Contact Keira Jessop
Regulation Number868.5730
Classification Product Code
BTR  
Date Received11/19/2024
Decision Date 08/13/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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