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510(k) K983101

BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 by C.R. Bard, Inc. — Product Code MJC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1998
Date Received
September 3, 1998
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological (Antimicrobial) And Accessories
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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Other clearances for product code MJC

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  • K000251 — SPECTRUM SILICONE FOLEY CATHETER (August 30, 2000)
  • K001143 — RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER (July 7, 2000)
  • K993464 — BARDEX I.C. PEDIATRIC FOLEY CATHETER (December 10, 1999)
  • K984136 — BARDEX LUBRI-SIL I.C. FOLEY CATHETER (February 16, 1999)
  • K971627 — SILICONE ANTIBACTERIAL FOLEY CATHETER (January 13, 1998)
  • K910318 — BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER (August 18, 1994)