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510(k) K873288

CLOSED FOLEY CATHETER SYSTEM by Todd Medical, Inc. — Product Code KNY

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
November 27, 1987
Date Received
August 17, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Catheter, G-U
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Todd Medical, Inc.

  • K873499 — TODD MEDICAL/SKILLED CARE PRODUCTS (November 24, 1987)
  • K873287 — IRRIGATION TRAY (W/120CC OF STERILE NORMAL SALINE) (November 13, 1987)
  • K873469 — TODD MEDICAL/SKILLED CARE PRODUCTS (October 29, 1987)
  • K850646 — ECLIPSE SELF ADHERING ELECTRODE (September 3, 1985)
  • K850004 — TRANSCUTANEOUS NERVE STIMULATOR FOR PAIN RELIEF (April 2, 1985)

Other clearances for product code KNY

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  • K162356 — Vesair Cystoscopic Sheath (March 2, 2017)
  • K140441 — BI-FLEX URETERAL ACCESS SHEATH (June 17, 2014)
  • K140562 — WIJAY EZ-VOID EXTERNAL CATHETER VALVE (June 16, 2014)
  • K141252 — GUARDIAN URETHRAL SHEATH (June 9, 2014)
  • K131803 — GUARDIAN URETHRAL SHEATH (August 20, 2013)
  • K123170 — VARI-PASS VARIABLE LENGTH ACCESS SHEATH (February 4, 2013)
  • K120160 — ROCAMED ROCAUS PLATINUM (May 14, 2012)
  • K112209 — PREFILLED CATHETER INFLATION SYRINGE (September 8, 2011)
  • K090121 — PRE-FILLED CATHETER INFLATION SYRINGE (April 15, 2009)