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510(k) K200757

Foley Catheter with Temperature Sensor by Deroyal Industries, Inc. — Product Code EYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2020
Date Received
March 24, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Upper Urinary Tract
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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Other clearances for product code EYC

  • K061918 — FOLEY CATHETERS WITH TEMPERATURE PROBE (August 18, 2006)
  • K041416 — EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER (July 2, 2004)
  • K925790 — EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S (May 17, 1993)
  • K890310 — STERILE FOLEY CATHETER (November 30, 1989)