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510(k) K200463

Huber Needle Infusion Set, Safety Huber Needle Infusion Set by Jiangsu Caina Medical Co.,Ltd — Product Code PTI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2021
Date Received
February 25, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Non-Coring (Huber) Needle
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

The non-coring needle (Huber) is utilized to gain access into a subcutaneous implanted intravascular infusion port but can also be used to access other non-vascular implanted devices with similar septums.

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