Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Intera Refill Kit

K-Number: K213823 · 2022-03-16

ApplicantIntera Oncology, Inc.
Decision Date2022-03-16
Product CodePTI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Intera Refill Kit is the device name listed in this FDA 510(k) record. The listed applicant is Intera Oncology, Inc.. It received FDA 510(k) clearance on 2022-03-16 under 510(k) number K213823. The device is classified under product code PTI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intera Refill Kit?

Intera Refill Kit is a medical device that received FDA 510(k) clearance on 2022-03-16. The listed applicant is Intera Oncology, Inc.. The 510(k) number is K213823.

When did Intera Refill Kit receive FDA 510(k) clearance?

Intera Refill Kit received FDA 510(k) clearance on 2022-03-16, under 510(k) number K213823.

Who is the listed applicant for Intera Refill Kit?

The FDA 510(k) record lists Intera Oncology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intera Refill Kit?

The FDA product code for Intera Refill Kit is PTI.

Other records listing Intera Oncology, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P890055Pump, infusion, implanted, programmableK211121Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep KitPMA P800036Pump, infusion, implanted, programmable

Related Devices (Code: PTI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252355K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSb-Kawasumi Laboratories, Inc.K251138Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd.K243332Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd.K241353PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle SetBard Access Systems, Inc.K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd.K211121Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep KitIntera Oncology, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑