FDA 510(k)

HydroMID 4F Single Lumen Midline Catheter

Número K: K220772 · 2022-12-07

Data da decisão2022-12-07

Código do produtoFOZ

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

HydroMID 4F Single Lumen Midline Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Access Vascular, Inc.. It received FDA 510(k) clearance on 2022-12-07 under 510(k) number K220772. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the HydroMID 4F Single Lumen Midline Catheter?

HydroMID 4F Single Lumen Midline Catheter is a medical device that received FDA 510(k) clearance on 2022-12-07. The listed applicant is Access Vascular, Inc.. The 510(k) number is K220772.

When did HydroMID 4F Single Lumen Midline Catheter receive FDA 510(k) clearance?

HydroMID 4F Single Lumen Midline Catheter received FDA 510(k) clearance on 2022-12-07, under 510(k) number K220772.

Who is the listed applicant for HydroMID 4F Single Lumen Midline Catheter?

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

What is the FDA product code for HydroMID 4F Single Lumen Midline Catheter?

The FDA product code for HydroMID 4F Single Lumen Midline Catheter is FOZ.

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Outros registros que listam Access Vascular, Inc. como candidato(a)

K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)K244059HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104)K243941HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204)K213550HydroPICC 5F Dual Lumen Catheter K203069HydroMID

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