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510(k) K182064

ExpanSure Transseptal Dilation System by Baylis Medical Company, Inc. — Product Code DRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2019
Date Received
August 1, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, For Percutaneous Catheterization
Device Class
Class II
Regulation Number
870.1310
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 DRE

  • K253616 — ProtekDilate Vascular Access Kit (December 19, 2025)
  • K251325 — VersaCross Connect™ Transseptal Dilator (May 29, 2025)
  • K242229 — Micro Ace Gold Advanced Micro Access System (January 15, 2025)
  • K241720 — VersaCross Connect™ Transseptal Dilator (July 12, 2024)
  • K233647 — VersaCross Connect™ Transseptal Dilator (December 14, 2023)
  • K232609 — Micro Ace™ Advanced Micro Access System (September 27, 2023)
  • K223472 — TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guard (December 15, 2022)
  • K212784 — TightRail Guardian Motorized Dilator Sheath (August 24, 2022)
  • K211679 — Xtractor device (February 17, 2022)
  • K210734 — Endovascular Dilator and Sets (April 6, 2021)