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510(k) K203179

Fortress Introducer Sheath System by Contract Medical International, GmbH — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2020
Date Received
October 26, 2020
Clearance Type
Special
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 Contract Medical International, GmbH

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  • K221914 — Catapult Guide Sheath (July 29, 2022)
  • K181463 — DuraSheath Introducer Sheath System (December 13, 2018)
  • K153197 — Fortress Introducer Sheath SYstem (January 11, 2016)
  • K142357 — DuraSheath Introducer Sheath System (June 25, 2015)

Other clearances for product code DYB

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  • 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)