Home / 510(k) Clearances / K984136

510(k) K984136

BARDEX LUBRI-SIL I.C. FOLEY CATHETER by Bard Medical Div. — Product Code MJC

K984136 is an FDA 510(k) premarket notification submitted by Bard Medical Div. for the device "BARDEX LUBRI-SIL I.C. FOLEY CATHETER". The FDA issued a decision of Substantially Equivalent on February 16, 1999. The device falls under product code MJC (Catheter, Urological (Antimicrobial) And Accessories), a Class II device regulated under 21 CFR 876.5130. Bard Medical Div. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1999
Date Received
November 18, 1998
Clearance Type
Traditional
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

Other clearances by Bard Medical Div.

  • K984084 — BARDEX LUBRI-SIL FOLEY CATHETER (February 1, 1999)
  • K970110 — BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019) (February 19, 1997)

Other clearances for product code MJC

  • K233094 — Wellead® Latex Foley Catheter (June 6, 2024)
  • K040658 — BARDEX I.C. LATEX FOLEY CATHETER (September 29, 2004)
  • K033477 — HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SY (June 10, 2004)
  • 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)
  • K983101 — BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 (November 3, 1998)
  • K971627 — SILICONE ANTIBACTERIAL FOLEY CATHETER (January 13, 1998)
  • K910318 — BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER (August 18, 1994)

FDA data resources