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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular Occluding, Temporary
510(k) Number K011656
Device Name HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771
Applicant
Micro Therapeutics, Inc.
2 Goodyear
Irvine,  CA  92618
Applicant Contact EBEN GORDON
Correspondent
Micro Therapeutics, Inc.
2 Goodyear
Irvine,  CA  92618
Correspondent Contact EBEN GORDON
Regulation Number870.4450
Classification Product Code
MJN  
Date Received05/29/2001
Decision Date 06/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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