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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 K042537
Device Name SUBMARINE PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SUVXXXXXXXXX
Applicant
INVATEC INNOVATIVE TECHNOLOGIES
4600 nathan lane north
plymouth,  MN  55442
Applicant Contact mike winegar
Correspondent
INVATEC INNOVATIVE TECHNOLOGIES
4600 nathan lane north
plymouth,  MN  55442
Correspodent Contact mike winegar
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/20/2004
Decision Date 11/08/2004
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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