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510(k) K232926

Novalung ultimate kit (US) by Fresenius Medical Care Renal Therapies Group, LLC — Product Code QJZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2024
Date Received
September 20, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
Device Class
Class II
Regulation Number
870.4100
Review Panel
CV
Submission Type

Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.

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Other clearances for product code QJZ

  • K240880 — VitalFlow Set with Balance Biosurface (September 12, 2024)
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