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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K896403
Device Name MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM
Applicant
Intensive Technology, Inc.
3574 Ruffin Rd.
San Diego,  CA  92123
Applicant Contact KEVIN E DALY
Correspondent
Intensive Technology, Inc.
3574 Ruffin Rd.
San Diego,  CA  92123
Correspondent Contact KEVIN E DALY
Regulation Number870.1250
Classification Product Code
LIT  
Date Received11/07/1989
Decision Date 03/06/1990
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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