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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K870542
Device Name VASCATH VASCULAR CATHETER PLACEMENT KIT
Applicant
Titan Medical, Inc.
1306 W. County Rd. F, #201
Arden Hills,  MN  55112
Applicant Contact JEFFREY M WILLIAMS
Correspondent
Titan Medical, Inc.
1306 W. County Rd. F, #201
Arden Hills,  MN  55112
Correspondent Contact JEFFREY M WILLIAMS
Regulation Number870.1340
Classification Product Code
DYB  
Date Received02/09/1987
Decision Date 04/27/1987
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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