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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 K972777
Device Name TEMPORARY OCCLUSION BALLOON SYSTEM
Applicant
Percu Surge, Inc.
777 N. Pastoria Ave.
Sunnyvale,  CA  94086
Applicant Contact EDWARD J SINCLAIR
Correspondent
Percu Surge, Inc.
777 N. Pastoria Ave.
Sunnyvale,  CA  94086
Correspondent Contact EDWARD J SINCLAIR
Regulation Number870.4450
Classification Product Code
MJN  
Date Received07/25/1997
Decision Date 03/11/1998
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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