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510(k) K000723

HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC) by Rochester Medical Corp. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2000
Date Received
March 6, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
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)
  • K033477 — HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SY (June 10, 2004)
  • K001143 — RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER (July 7, 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)

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