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FDA 510(k)

AeroJet Ventilation Catheter

K-Number: K243579 · 2025-08-13

ApplicantPipeline Medical Products, LLC
Decision Date2025-08-13
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AeroJet Ventilation Catheter is a medical device manufactured by Pipeline Medical Products, LLC. It received FDA 510(k) clearance on 2025-08-13 under approval number K243579. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AeroJet Ventilation Catheter?

AeroJet Ventilation Catheter is a medical device that received FDA 510(k) clearance on 2025-08-13. It is manufactured by Pipeline Medical Products, LLC. The 510(k) number is K243579.

When was AeroJet Ventilation Catheter approved by the FDA?

AeroJet Ventilation Catheter received FDA 510(k) clearance on 2025-08-13, under approval number K243579.

What company makes AeroJet Ventilation Catheter?

AeroJet Ventilation Catheter is manufactured by Pipeline Medical Products, LLC.

What is the FDA product code for AeroJet Ventilation Catheter?

The FDA product code for AeroJet Ventilation Catheter is BTR.

Related Clinical Trials

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Related Devices (Code: BTR)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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