FDA 510(k)

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

Número K: K211121 · 2021-10-14

Data da decisão2021-10-14

Código do produtoPTI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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