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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dislodger, Stone, Biliary
510(k) Number K891588
Device Name TRI-LUMEN INTRA VASCULAR BALLOON CATHETER (GU USE)
Applicant
Ideal Medical, Inc.
12167 49th St. N.
P.O. Box 17327
Clearwater,  FL  34622
Applicant Contact LORNA K LINVILLE
Correspondent
Ideal Medical, Inc.
12167 49th St. N.
P.O. Box 17327
Clearwater,  FL  34622
Correspondent Contact LORNA K LINVILLE
Regulation Number876.5010
Classification Product Code
LQR  
Date Received03/17/1989
Decision Date 09/28/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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