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510(k) K092014

SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER by Onset Medical Corporation — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2009
Date Received
July 6, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by Onset Medical Corporation

  • K152498 — SoloPath Re-Collapsible Access System (January 5, 2016)
  • K121404 — SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM (May 3, 2013)
  • K112629 — ONSET ACCESS CATHETER SYSTEM (October 11, 2011)
  • K100819 — THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER (August 2, 2010)
  • 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)
  • K043254 — PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH (February 10, 2005)

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