Cleared Traditional

AeroJet Ventilation Catheter

K243579 · Pipeline Medical Products, LLC · Anesthesiology
Aug 2025
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K243579 is an FDA 510(k) clearance for the AeroJet Ventilation Catheter, a Tube, Tracheal (w/wo Connector) (Class II — Special Controls, product code BTR), submitted by Pipeline Medical Products, LLC (Weymouth, US). The FDA issued a Cleared decision on August 13, 2025, 267 days after receiving the submission on November 19, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5730.

Submission Details

510(k) Number K243579 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 2024
Decision Date August 13, 2025
Days to Decision 267 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTR — Tube, Tracheal (w/wo Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5730

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