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510(k) K212567

PVC Hydrophilic Urethral Catheter by Chengdu Daxan Innovative Medical Tech. Co., Ltd. — Product Code EZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2022
Date Received
August 16, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Straight
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Chengdu Daxan Innovative Medical Tech. Co., Ltd.

  • K243175 — Disposable Intermittent Catheter (TPU Catheter) (June 26, 2025)

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  • K250659 — LoFric Origo (September 26, 2025)
  • K250699 — Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twi (July 1, 2025)
  • K251116 — Luja Coudé (June 27, 2025)
  • K243175 — Disposable Intermittent Catheter (TPU Catheter) (June 26, 2025)
  • K250270 — Luja Set (April 17, 2025)
  • K242049 — SureCath Set (November 26, 2024)