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FDA 510(k)

Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit

K-Number: K211121 · 2021-10-14

ApplicantIntera Oncology, Inc.
Decision Date2021-10-14
Product CodePTI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep 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 2021-10-14 under 510(k) number K211121. 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 Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit?

Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit is a medical device that received FDA 510(k) clearance on 2021-10-14. The listed applicant is Intera Oncology, Inc.. The 510(k) number is K211121.

When did Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit receive FDA 510(k) clearance?

Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit received FDA 510(k) clearance on 2021-10-14, under 510(k) number K211121.

Who is the listed applicant for Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep 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 Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit?

The FDA product code for Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep 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, programmableK213823Intera Refill 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.K213823Intera Refill 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.

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