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510(k) K221914

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2022
Date Received
June 30, 2022
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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  • 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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