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510(k) K043254

PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH by Onset Medical Corporation — Product Code EZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2005
Date Received
November 24, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Catheter, Ureteral
Device Class
Class II
Regulation Number
876.5470
Review Panel
GU
Submission Type

Other clearances by Onset Medical Corporation

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  • K100819 — THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER (August 2, 2010)
  • K092014 — SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER (October 8, 2009)
  • K062852 — BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870 (February 23, 2007)
  • K061009 — PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS (May 2, 2006)

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  • K172588 — Balloon Catheter and Balloon Ureteral Dilator Set (April 19, 2018)
  • K170531 — Ureteral Dilators and Percutaneous Nephrostomy Dilators (August 17, 2017)
  • K132181 — GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER (October 21, 2013)