510(k) K170881

ISP Safety Huber Needle Infusion Set by Infusion Safety Products, Inc. — Product Code PTI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 14, 2017
Date Received: March 24, 2017
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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