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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stripper, Artery, Intraluminal
510(k) Number K890515
Device Name PERIPHERAL ATHERECTOMY SYSTEM
Applicant
Intensive Technology, Inc.
3574 Ruffin Rd.
San Diego,  CA  92123
Applicant Contact R CRAWFORD
Correspondent
Intensive Technology, Inc.
3574 Ruffin Rd.
San Diego,  CA  92123
Correspondent Contact R CRAWFORD
Regulation Number870.4875
Classification Product Code
DWX  
Date Received02/01/1989
Decision Date 05/23/1989
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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