Home / 510(k) Clearances / K163268

510(k) K163268

FlexCath Select Steerable Shealth and Dilator by Medtronic Cryocath, LP — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2017
Date Received
November 21, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
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)
  • 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)

Other clearances for product code DYB

  • K260163 — AuST CSP Introducer (February 19, 2026)
  • K254236 — Peel-Away Introducer Sheath (February 9, 2026)
  • K253652 — Genie MAX Large Bore Introducer Sheath (January 22, 2026)
  • K252508 — Intri26 Introducer Sheath (December 17, 2025)
  • K253741 — V•Stick™ Vascular Access Set (December 15, 2025)
  • K252309 — PerQseal Introducers (October 23, 2025)
  • K251838 — Introducer Sheath Set (October 21, 2025)
  • K252766 — 14Fr Low Profile Introducer Kit (October 8, 2025)
  • K252441 — Primero Safe Access System (September 29, 2025)
  • K252227 — Pounce(TM) Sheath (September 24, 2025)