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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K940063
Device Name MEDTRONIC INTERVENTIONAL VASCULAR Y-ADAPTER, TRI-ADAPTER, TRI-ADAPTER & ACCESSORY PACKS
Applicant
MEDTRONICS INTERVENTIONAL VASCULAR
37A CHERRY HILL DR.
DANVERS,  MA  01923
Applicant Contact TIMOTHY J JOHNSON
Correspondent
MEDTRONICS INTERVENTIONAL VASCULAR
37A CHERRY HILL DR.
DANVERS,  MA  01923
Correspondent Contact TIMOTHY J JOHNSON
Regulation Number870.1250
Classification Product Code
LIT  
Date Received01/06/1994
Decision Date 03/29/1994
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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