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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 K882826
Device Name SOFTRAC-PTA PERIPHERAL DILATATION CATHETER
Applicant
Schneider-Shilley (Usa)
2905 Northwest Blvd.
Minneapolis,  MN  55441
Applicant Contact HOWARD B WITTELS
Correspondent
Schneider-Shilley (Usa)
2905 Northwest Blvd.
Minneapolis,  MN  55441
Correspondent Contact HOWARD B WITTELS
Regulation Number870.1250
Classification Product Code
LIT  
Date Received07/08/1988
Decision Date 01/24/1989
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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