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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wire, guide, catheter
510(k) Number K962572
Device Name SCIMED CHOICE PT VISION PTCA GUIDE WIRE
Applicant
SCIMED LIFE SYSTEMS, INC.
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
Applicant Contact CONNIE J DEL TORO
Correspondent
SCIMED LIFE SYSTEMS, INC.
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
Correspondent Contact CONNIE J DEL TORO
Regulation Number870.1330
Classification Product Code
DQX  
Date Received07/01/1996
Decision Date 12/17/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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