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FDA 510(k)

HydroPICC 5F Dual Lumen Catheter

K-Number: K213550 · 2022-05-04

ApplicantAccess Vascular, Inc.
Decision Date2022-05-04
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HydroPICC 5F Dual Lumen Catheter is a medical device manufactured by Access Vascular, Inc.. It received FDA 510(k) clearance on 2022-05-04 under approval number K213550. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HydroPICC 5F Dual Lumen Catheter?

HydroPICC 5F Dual Lumen Catheter is a medical device that received FDA 510(k) clearance on 2022-05-04. It is manufactured by Access Vascular, Inc.. The 510(k) number is K213550.

When was HydroPICC 5F Dual Lumen Catheter approved by the FDA?

HydroPICC 5F Dual Lumen Catheter received FDA 510(k) clearance on 2022-05-04, under approval number K213550.

What company makes HydroPICC 5F Dual Lumen Catheter?

HydroPICC 5F Dual Lumen Catheter is manufactured by Access Vascular, Inc..

What is the FDA product code for HydroPICC 5F Dual Lumen Catheter?

The FDA product code for HydroPICC 5F Dual Lumen Catheter is LJS.

Related Clinical Trials

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Other Devices by Access Vascular, Inc.

K172885HydroPICC K193015HydroPICC (PICC-142) K203069HydroMID K220772HydroMID 4F Single Lumen Midline 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: LJS)

K160925VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) K162443PowerPICC Provena CathetersC.R. Bard, Inc. K161496Turbo-Flo PICC SetsCook Incorporated K161765CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex K153469Cathtong I PICC CatheterL&Z Us, Inc. K151985PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH CatheterC.R. Bard, 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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