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510(k) K981612

ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER by Rochester Medical Corp. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1998
Date Received
May 6, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Retention Type, Balloon
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)
  • K000723 — HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-H (May 19, 2000)
  • 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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