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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
510(k) Number K882289
Device Name ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH.
Applicant
Aries Medical, Inc.
Two Gill St.
Woburn,  MA  01801
Applicant Contact BARRY V ASHAR
Correspondent
Aries Medical, Inc.
Two Gill St.
Woburn,  MA  01801
Correspondent Contact BARRY V ASHAR
Regulation Number870.3450
Classification Product Code
DSY  
Date Received06/01/1988
Decision Date 12/12/1988
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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