Home / 510(k) Clearances / K190688

510(k) K190688

VersaCross Steerable Sheath, VersaCross Transseptal Dilator by Baylis Medical Company, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2019
Date Received
March 18, 2019
Clearance Type
Special
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 Baylis Medical Company, Inc.

  • K251325 — VersaCross Connect™ Transseptal Dilator (May 29, 2025)
  • K241720 — VersaCross Connect™ Transseptal Dilator (July 12, 2024)
  • K231227 — SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath (December 20, 2023)
  • K233647 — VersaCross Connect™ Transseptal Dilator (December 14, 2023)
  • K213898 — ProTrack Pigtail Wire (March 1, 2023)
  • K221351 — Mechanical Guidewire (December 19, 2022)
  • K213582 — Epicardial Access System (June 30, 2022)
  • K220414 — VersaCross Connect Transseptal Dilator (May 9, 2022)
  • K201288 — ExpanSure Large Access Transseptal Dilator (June 12, 2020)
  • K191546 — Epicardial Access System (August 2, 2019)

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)