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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 K915347
Device Name SCIMED VIPER CATHETER
Applicant
Scimed
6655 Wedgewood Rd.
Maple Grove,  MN  55369
Applicant Contact DARLENE THOMETZ
Correspondent
Scimed
6655 Wedgewood Rd.
Maple Grove,  MN  55369
Correspondent Contact DARLENE THOMETZ
Regulation Number870.1250
Classification Product Code
LIT  
Date Received11/26/1991
Decision Date 08/17/1992
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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