Home / 510(k) Clearances / K062852

510(k) K062852

BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870 by Onset Medical Corporation — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2007
Date Received
September 25, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
  • K092014 — SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER (October 8, 2009)
  • 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)

Other clearances for product code DYB

  • K260163 — AuST CSP Introducer (February 19, 2026)
  • K254236 — Peel-Away Introducer Sheath (February 9, 2026)
  • K253652 — Genie MAX Large Bore Introducer Sheath (January 22, 2026)
  • K252508 — Intri26 Introducer Sheath (December 17, 2025)
  • K253741 — V•Stick™ Vascular Access Set (December 15, 2025)
  • K252309 — PerQseal Introducers (October 23, 2025)
  • K251838 — Introducer Sheath Set (October 21, 2025)
  • K252766 — 14Fr Low Profile Introducer Kit (October 8, 2025)
  • K252441 — Primero Safe Access System (September 29, 2025)
  • K252227 — Pounce(TM) Sheath (September 24, 2025)