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510(k) K222603

6F Wallaby Long Sheath by Wallaby Medical, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2023
Date Received
August 29, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by Wallaby Medical, Inc.

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  • K223139 — Wallaby 017 Micro Catheter (April 25, 2023)
  • K211697 — Esperance Aspiration Catheter System (November 16, 2021)
  • K173711 — Wallaby Avenir Coil System (May 4, 2018)

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