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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Embolectomy
510(k) Number K914880
Device Name DUAL BALLOON EMBOLECTOMY CATHETER
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 Number870.5150
Classification Product Code
DXE  
Date Received10/30/1991
Decision Date 03/16/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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