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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope Accessory
510(k) Number K254040
Device Name LungFlow Basket Catheter
Applicant
Free Flow Medical, Inc.
44380 S Grimmer Blvd.
Fremont,  CA  94538
Applicant Contact Mark Mathis
Correspondent
Free Flow Medical, Inc.
44380 S Grimmer Blvd.
Fremont,  CA  94538
Correspondent Contact Mark Mathis
Regulation Number874.4680
Classification Product Code
KTI  
Date Received12/16/2025
Decision Date 03/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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