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FDA 510(k)

HydroMID

K-Number: K203069 · 2021-02-08

ApplicantAccess Vascular, Inc.
Decision Date2021-02-08
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HydroMID is a medical device manufactured by Access Vascular, Inc.. It received FDA 510(k) clearance on 2021-02-08 under approval number K203069. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HydroMID?

HydroMID is a medical device that received FDA 510(k) clearance on 2021-02-08. It is manufactured by Access Vascular, Inc.. The 510(k) number is K203069.

When was HydroMID approved by the FDA?

HydroMID received FDA 510(k) clearance on 2021-02-08, under approval number K203069.

What company makes HydroMID?

HydroMID is manufactured by Access Vascular, Inc..

What is the FDA product code for HydroMID?

The FDA product code for HydroMID is FOZ.

Other Devices by Access Vascular, Inc.

K172885HydroPICC K193015HydroPICC (PICC-142) K220772HydroMID 4F Single Lumen Midline Catheter K213550HydroPICC 5F Dual Lumen Catheter 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)

View all 9 devices →

Related Devices (Code: FOZ)

K162894AccuCath Intravascular CatheterC.R. Bard, Inc. K161779MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV CatheterMedsource International, LLC K162377PowerGlide Pro Midline CatheterC.R. Bard, Inc. K161866BioFlo Midline CatheterNavilyst Medical, Inc. K161777BD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc. K160592SUPERCATH 6Togo Medikit Co., Ltd.

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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