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510(k) K142684

FlexCath Select Steerable Sheath (10 French) by Medtronic Cryocath, LP — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2014
Date Received
September 19, 2014
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)
  • K163268 — FlexCath Select Steerable Shealth and Dilator (February 2, 2017)
  • 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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