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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 K864537
Device Name 40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER
Applicant
Aries Medical, Inc.
Two Gill St.
Woburn,  MA  01801
Applicant Contact BARRY ASHER
Correspondent
Aries Medical, Inc.
Two Gill St.
Woburn,  MA  01801
Correspondent Contact BARRY ASHER
Regulation Number870.3535
Classification Product Code
DSP  
Date Received11/17/1986
Decision Date 06/19/1987
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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