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U.S. Department of Health and Human Services

510(k) Premarket Notification
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ProductCode: MJC Applicant: C.R. BARD, INC. Decision Date To: 05/29/2024
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bardex all-silicone, bardex lubri-sil, and bardex lubri-sil i.c. temperature-sensing foley catheters C.R. BARD, INC. K070582 12/07/2007
bardex lubri-sil and bardex lubri-sil i.c. anti-infective all-silicone foley catheters C.R. BARD, INC. K070558 12/07/2007
bardex i.c. latex foley catheter C.R. BARD, INC. K040658 09/29/2004
bardex latex-free temperature-sensing foley catheter (uncoated); bardex lubri-sil temperature-sensing foley catheter (lu C.R. BARD, INC. K003289 01/05/2001
bard all-silicone 3-way foley catheter; bard lubri-sil 3-way foley catheter; bard lubri-sil i.c. 3-way foley catheter C.R. BARD, INC. K002868 12/08/2000
bardex i.c. pediatric foley catheter C.R. BARD, INC. K993464 12/10/1999
bardex i.c 4-way foley catheter model 1865sixx xx = 18,20,22,24 C.R. BARD, INC. K983101 11/03/1998
bard(r) hydrogel/silver-coated foley catheter C.R. BARD, INC. K910318 08/18/1994
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