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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 K844800
Device Name OPTI-FLOW & OPTI-TORQUE ANGIOGRAPHIC CATHETERS
Applicant
Vas-Cath of Canada , Ltd.
2380 Tedlo St. Mississauga
Ontario, L5a 3v3,  CA
Applicant Contact KAMAL KALWANI
Correspondent
Vas-Cath of Canada , Ltd.
2380 Tedlo St. Mississauga
Ontario, L5a 3v3,  CA
Correspondent Contact KAMAL KALWANI
Regulation Number870.1200
Classification Product Code
DQO  
Date Received12/11/1984
Decision Date 05/16/1985
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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