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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 K850760
Device Name MILLS OPERATIVE PERIPHERAL ANGIOPLASTY CATHETER
Applicant
Scimed Life Systems, Inc.
13000 County Rd. 6
Minneapolis,  MN  55441
Applicant Contact DARLENE A THOMETZ
Correspondent
Scimed Life Systems, Inc.
13000 County Rd. 6
Minneapolis,  MN  55441
Correspondent Contact DARLENE A THOMETZ
Regulation Number870.1250
Classification Product Code
LIT  
Date Received02/25/1985
Decision Date 04/10/1985
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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