Home / 510(k) Clearances / K123591

510(k) K123591

FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) by Medtronic Cryocath, LP — Product Code DRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2012
Date Received
November 21, 2012
Clearance Type
Special
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

  • K202620 — FlexCath Advance Steerable Sheath and Dilator (November 13, 2020)
  • 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)
  • K102176 — FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MOD (September 1, 2010)

Other clearances for product code DRA

  • K250529 — Globe Introducer (601-01001) (June 3, 2025)
  • 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)
  • 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)