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510(k) K222279

Rusch Intermittent Urethral Catheters by Teleflex Medical — Product Code EZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2022
Date Received
July 29, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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Other clearances for product code EZC

  • K173596 — Rusch Intermittent Urethral Catheters (January 29, 2018)
  • K946282 — UNIVERSAL URETHRAL CATHETER (March 31, 1995)
  • K913341 — BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER (January 27, 1992)
  • K910846 — BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF (August 16, 1991)
  • K910197 — HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS (August 9, 1991)
  • K910195 — BARD HYDROGEL-COATED FOLEY CATHETERS (August 9, 1991)