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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 K923826
Device Name PARAMETRIC PROCESS CONTROL
Applicant
Scimed Life Systems, Inc.
6655 Wedgwood Rd.
Maple Grove,  MN  55369
Applicant Contact ANGELA JONES
Correspondent
Scimed Life Systems, Inc.
6655 Wedgwood Rd.
Maple Grove,  MN  55369
Correspondent Contact ANGELA JONES
Regulation Number870.1250
Classification Product Code
LIT  
Date Received07/30/1992
Decision Date 10/22/1992
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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