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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 the device name listed in this FDA 510(k) record. The listed applicant is Pipeline Medical Products, LLC. It received FDA 510(k) clearance on 2025-08-13 under 510(k) 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. The listed applicant is Pipeline Medical Products, LLC. The 510(k) number is K243579.

When did AeroJet Ventilation Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for AeroJet Ventilation Catheter?

The FDA 510(k) record lists Pipeline Medical Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AeroJet Ventilation Catheter?

The FDA product code for AeroJet Ventilation Catheter is BTR.

Related Devices (Code: BTR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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