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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Balloon, Intra-Aortic And Control
510(k) Number K864567
Device Name 40CC PERCUTANEOUS FURL DOU. LUMEN BALLOON CATHETER
Applicant
Aries Medical, Inc.
Two Gill St.
Woburn,  MA  01801
Applicant Contact MICHAEL L RISHTON
Correspondent
Aries Medical, Inc.
Two Gill St.
Woburn,  MA  01801
Correspondent Contact MICHAEL L RISHTON
Regulation Number870.3535
Classification Product Code
DSP  
Date Received11/19/1986
Decision Date 05/12/1987
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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