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510(k) K841511

HAEMATURIA CATHETERS by Warne Surgical Products, Ltd. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1984
Date Received
April 11, 1984
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 Warne Surgical Products, Ltd.

  • K850694 — WSP CODE 4310 STRESSCATH (May 17, 1985)
  • K850696 — WSP CODE 4300 DIOMASTER DIAGNOSTIC (May 17, 1985)
  • K850695 — WSP CODE 4301 DIOMASTER THERAPEUTIC (May 16, 1985)
  • K850693 — WSP CODE 4315 PADTEST (May 10, 1985)
  • K840687 — KIDNEY TRANSPLANT CATHETER (June 7, 1984)
  • K841409 — BUSH NECK W/PLUG (April 18, 1984)
  • K841412 — ROLLED NECK W/TAP (April 18, 1984)
  • K841410 — BUSH NECK W/TAP (April 18, 1984)
  • K841411 — ROLLED NECK W/PLUG (April 18, 1984)
  • K840702 — SECURE W/25MM DIAM. SHEATH & ADHESIVE (March 22, 1984)

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  • K211032 — Urinary Catheter 12 Fr, Urinary Catheter 16 Fr (November 19, 2021)
  • K181979 — Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter (May 24, 2019)
  • K180354 — UroGen Ureteral Catheter (October 30, 2018)
  • K181144 — Angled Tip Ureteral Catheter (June 28, 2018)
  • K180530 — Imager II Urology Torque Catheter (April 10, 2018)
  • K171810 — Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter (March 7, 2018)
  • K171600 — Renal Access Cobra Catheter, Kumpe Access Catheter (February 16, 2018)