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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K935425
Device Name METRONIC BUCHBINDER ENVOY PERCUTANEOUS CATHETERS
Applicant
Medtronics Interventional Vascular
9410 Carroll Park Dr.
San Diego,  CA  92121
Applicant Contact TIMOTHY J JOHNSON
Correspondent
Medtronics Interventional Vascular
9410 Carroll Park Dr.
San Diego,  CA  92121
Correspondent Contact TIMOTHY J JOHNSON
Regulation Number870.1250
Classification Product Code
DQY  
Date Received11/10/1993
Decision Date 04/26/1994
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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