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510(k) K240957

Catapult Guide Sheath by Contract Medical International, GmbH — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2024
Date Received
April 8, 2024
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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  • K203179 — Fortress Introducer Sheath System (November 20, 2020)
  • K181463 — DuraSheath Introducer Sheath System (December 13, 2018)
  • K153197 — Fortress Introducer Sheath SYstem (January 11, 2016)
  • K142357 — DuraSheath Introducer Sheath System (June 25, 2015)

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  • 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)
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  • K252227 — Pounce(TM) Sheath (September 24, 2025)