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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urethral
510(k) Number K191512
Device Name LotusCatheter (Lotus No Balloon Catheter)
Applicant
Hakki Medical Technologies, Inc.
10333 Seminole Blvd., Suite #8
Largo,  FL  33778
Applicant Contact Shereen Said Hakky
Correspondent
Hakki Medical Technologies, Inc.
5414 Leilani Dr.
St. Petersburg Beach,  FL  33778
Correspondent Contact John Samorajczyk
Regulation Number876.5130
Classification Product Code
GBM  
Subsequent Product Code
FEW  
Date Received06/07/2019
Decision Date 05/21/2020
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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