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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 K072283
Device Name DORADO PTA BALLOON DILATATION CATHETER
Applicant
BARD PERIPHERAL VASCULAR, INC.
1415 WEST 3RD ST.
TEMPE,  AZ  85281
Applicant Contact GENEVIEVE BALUTOWSKI
Correspondent
CITECH
5200 BUTLER PIKE
PLYMOUTH MEETING,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
LIT  
Date Received08/16/2007
Decision Date 09/19/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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