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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peripheral, Atherectomy
510(k) Number K954604
Device Name ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE; HTI FLOPPY
Applicant
Heart Technology Mfg., Inc.
17425 NE Union Hill Rd.
Redmond,  WA  98052
Applicant Contact DIANE JOHNSON
Correspondent
Heart Technology Mfg., Inc.
17425 NE Union Hill Rd.
Redmond,  WA  98052
Correspondent Contact DIANE JOHNSON
Regulation Number870.4875
Classification Product Code
MCW  
Date Received10/04/1995
Decision Date 01/18/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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