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510(k) K251831

Bio-Medicus Life Support Catheter and Introducer by Medtronic, Inc. — Product Code QHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2026
Date Received
June 13, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single Lumen Ecmo Cannula
Device Class
Class II
Regulation Number
870.4100
Review Panel
CV
Submission Type

Single-lumen cannulas/catheters to be used with an extracorporeal circuit intended for use in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

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Other clearances for product code QHW

  • K240534 — Bio-Medicus Life Support Catheter and Introducer (April 19, 2024)
  • K201057 — Bio-Medicus Life Support Catheter and Introducer (January 14, 2022)