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510(k) K202620

FlexCath Advance Steerable Sheath and Dilator by Medtronic Cryocath, LP — Product Code DRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2020
Date Received
September 10, 2020
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 Medtronic Cryocath, LP

  • K183174 — FlexCath Advance Steerable Sheath and Dilator (November 26, 2018)
  • K163268 — FlexCath Select Steerable Shealth and Dilator (February 2, 2017)
  • K142684 — FlexCath Select Steerable Sheath (10 French) (November 6, 2014)
  • K123591 — FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) (December 27, 2012)
  • K102176 — FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MOD (September 1, 2010)

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  • K233248 — FARADRIVE™ Steerable Sheath (December 11, 2023)
  • K232321 — FlexCath Contour™ Steerable Sheath (October 31, 2023)
  • K223824 — POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping (March 22, 2023)
  • K221397 — MitraClip G4 Steerable Guide Catheter (September 28, 2022)
  • K221044 — AcQGuide® VUE Steerable Sheath (May 5, 2022)
  • K211100 — AcQGuide MAX Steerable Sheath (May 14, 2021)
  • 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)