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510(k) K243436

Seclusion Catheter by Basis Medical — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2025
Date Received
November 5, 2024
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

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