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510(k) K212077

Teleflex Rusch SoftSimplastic Foley Catheters by Teleflexmedical, Inc. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2023
Date Received
July 2, 2021
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

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Other clearances for product code EZL

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  • K240057 — TraumaGuard Intra-abdominal Pressure Sensing System (April 17, 2024)
  • K233411 — Folysil Silicone Catheter (April 15, 2024)
  • K233013 — 2-Way 100% Silicone Cleartract Catheter (January 23, 2024)
  • K231101 — Flume Catheter (June 29, 2023)
  • K221020 — Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accu (January 13, 2023)
  • K222118 — 2-Way 100% Silicone Cleartract Catheter (December 1, 2022)