ISP Safety Huber Needle Infusion Set— 510(k) K170881

Name: FDA 510(k) clearance K170881
Creator: U.S. Food and Drug Administration
Published: 2017-12-14

Substantially Equivalent

Infusion Safety Products, Inc.

FDA 510(k) clearance K170881 for ISP Safety Huber Needle Infusion Set, Substantially Equivalent on 2017-12-14. Applicant: Infusion Safety Products, Inc.. Device class: 2.

Clearance details

Applicant: Infusion Safety Products, Inc.
Product code: Code PTI
Device class: Class 2
Regulation: 21 CFR 880.5570
Advisory panel: General Hospital
Date received: 2017-03-24
Decision date: 2017-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Keene, NH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PTI

view all

K252355 — K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing2025-11-26
K251138 — Promisemed Safety Huber Needles2025-05-13
K243332 — Promisemed Safety Huber Needles2025-03-14
K241353 — PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set2024-11-27
K230715 — Promisemed Safety Huber Needle2023-06-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.