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510(k) K792719

3 WAY URETHRAL IRRIGATION CATHETER by Vesta, Inc. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1980
Date Received
December 28, 1979
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 Vesta, Inc.

  • K834078 — SILICONE RUGGER DISPOSABLE YOKE-CPAP (December 27, 1983)
  • K810960 — NASOPHARYNGEAL AIRWAY (April 23, 1981)
  • K792018 — SILICONE RUBBER-BI NASOPHARYNGEAL AIR (November 13, 1979)

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  • 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)