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510(k) K061009

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2006
Date Received
April 12, 2006
Clearance Type
Special
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

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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)
  • K043254 — PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH (February 10, 2005)

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