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510(k) K250529

Globe Introducer (601-01001) by Kardium, Inc. — Product Code DRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2025
Date Received
February 24, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Steerable
Device Class
Class II
Regulation Number
870.1280
Review Panel
CV
Submission Type

Other clearances by Kardium, Inc.

  • K250747 — Globe® Pulsed Field System (June 25, 2025)

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  • K221044 — AcQGuide® VUE Steerable Sheath (May 5, 2022)
  • K211100 — AcQGuide MAX Steerable Sheath (May 14, 2021)
  • K202620 — FlexCath Advance Steerable Sheath and Dilator (November 13, 2020)
  • K192422 — Steerable Introducer 12F (October 4, 2019)
  • K190167 — MitraClip G4 Steerable Guide Catheter (May 29, 2019)
  • K183174 — FlexCath Advance Steerable Sheath and Dilator (November 26, 2018)