Intera Refill Kit— 510(k) K213823

Substantially Equivalent

Intera Oncology, Inc.

FDA 510(k) clearance K213823 for Intera Refill Kit, Substantially Equivalent on 2022-03-16. Applicant: Intera Oncology, Inc.. Device class: 2.

Clearance details

Applicant: Intera Oncology, Inc.
Product code: Code PTI
Device class: Class 2
Regulation: 21 CFR 880.5570
Advisory panel: General Hospital
Date received: 2021-12-08
Decision date: 2022-03-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Wellesley, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PTI

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

More clearances from Intera Oncology, Inc.

K211121 — Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit2021-10-14

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