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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name filter, intravascular, cardiovascular
510(k) Number K052578
Device Name BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J
Applicant
BARD PERIPHERAL VASCULAR, INC.
1415 WEST 3RD ST.
TEMPE,  AZ  85281
Applicant Contact GENEVIEVE BALUTOWSKI
Correspondent
BARD PERIPHERAL VASCULAR, INC.
1415 WEST 3RD ST.
TEMPE,  AZ  85281
Correspondent Contact GENEVIEVE BALUTOWSKI
Regulation Number870.3375
Classification Product Code
DTK  
Date Received09/20/2005
Decision Date 11/25/2005
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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