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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Nephrostomy
510(k) Number K063632
Device Name X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER
Applicant
C.R. Bard, Inc.
13183 Harland Dr.
Covington,  GA  30014
Applicant Contact TERRI MORRIS
Correspondent
C.R. Bard, Inc.
13183 Harland Dr.
Covington,  GA  30014
Correspondent Contact TERRI MORRIS
Classification Product Code
LJE  
Date Received12/06/2006
Decision Date 01/05/2007
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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