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510(k) K102176

FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10 by Medtronic Cryocath, LP — Product Code DRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2010
Date Received
August 3, 2010
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

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  • K142684 — FlexCath Select Steerable Sheath (10 French) (November 6, 2014)
  • K123591 — FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) (December 27, 2012)

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