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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stylet, Catheter
510(k) Number K040001
Device Name STEERABLE STYLET
Applicant
Synovis Surgical Innovations
2575 University Ave.
St. Paul,  MN  55114
Applicant Contact JAMES JENKINS
Correspondent
Synovis Surgical Innovations
2575 University Ave.
St. Paul,  MN  55114
Correspondent Contact JAMES JENKINS
Regulation Number870.1380
Classification Product Code
DRB  
Date Received01/02/2004
Decision Date 03/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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