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510(k) K201288

ExpanSure Large Access Transseptal Dilator by Baylis Medical Company, Inc. — Product Code DRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2020
Date Received
May 14, 2020
Clearance Type
Special
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.

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  • 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)
  • K191546 — Epicardial Access System (August 2, 2019)
  • K183632 — Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology (June 7, 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)