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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K910987
Device Name 7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE
Applicant
Scimed
13010 County Rd. 6
Minneapolis,  MN  55441
Applicant Contact DAVID A TEICHER
Correspondent
Scimed
13010 County Rd. 6
Minneapolis,  MN  55441
Correspondent Contact DAVID A TEICHER
Regulation Number870.1200
Classification Product Code
DQO  
Date Received03/07/1991
Decision Date 05/29/1991
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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