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510(k) K033477

HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT by Rochester Medical Corp. — Product Code MJC

K033477 is an FDA 510(k) premarket notification submitted by Rochester Medical Corp. for the device "HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT". The FDA issued a decision of Substantially Equivalent on June 10, 2004. The device falls under product code MJC (Catheter, Urological (Antimicrobial) And Accessories), a Class II device regulated under 21 CFR 876.5130. Rochester Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2004
Date Received
November 3, 2003
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 Rochester Medical Corp.

  • K122785 — HYDROSIL; MAGIC; PERSONAL CATHETER (May 14, 2013)
  • K001143 — RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER (July 7, 2000)
  • K000723 — HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-H (May 19, 2000)
  • K981612 — ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, T (July 8, 1998)
  • K971627 — SILICONE ANTIBACTERIAL FOLEY CATHETER (January 13, 1998)
  • K970704 — PERSONAL CATHETER (March 13, 1997)
  • K952082 — ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER (July 18, 1995)
  • K941692 — FEMALE LENGTH ALL SILICONE UROLOGICAL CATHETER (March 6, 1995)
  • K943851 — ALL SILICONE INTERMITTENT CATHETER (January 31, 1995)
  • K923136 — MALE EXTERNAL CATHETER (December 3, 1992)

Other clearances for product code MJC

  • K233094 — Wellead® Latex Foley Catheter (June 6, 2024)
  • K040658 — BARDEX I.C. LATEX FOLEY CATHETER (September 29, 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)
  • K984136 — BARDEX LUBRI-SIL I.C. FOLEY CATHETER (February 16, 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