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FDA 510(k)

HydroPICC (PICC-142)

K-Number: K193015 · 2020-02-20

ApplicantAccess Vascular, Inc.
Decision Date2020-02-20
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HydroPICC (PICC-142) is a medical device manufactured by Access Vascular, Inc.. It received FDA 510(k) clearance on 2020-02-20 under approval number K193015. 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 (PICC-142)?

HydroPICC (PICC-142) is a medical device that received FDA 510(k) clearance on 2020-02-20. It is manufactured by Access Vascular, Inc.. The 510(k) number is K193015.

When was HydroPICC (PICC-142) approved by the FDA?

HydroPICC (PICC-142) received FDA 510(k) clearance on 2020-02-20, under approval number K193015.

What company makes HydroPICC (PICC-142)?

HydroPICC (PICC-142) is manufactured by Access Vascular, Inc..

What is the FDA product code for HydroPICC (PICC-142)?

The FDA product code for HydroPICC (PICC-142) is LJS.

Other Devices by Access Vascular, Inc.

K172885HydroPICC K203069HydroMID 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: 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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