FDA 510(k)

Pentaflush

K-Number: K214080 · 2022-07-20

Decision Date2022-07-20

Product CodeNGT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Pentaflush is a medical device manufactured by Pentaferte Italia S.R.L.. It received FDA 510(k) clearance on 2022-07-20 under approval number K214080. The device is classified under product code NGT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pentaflush?

Pentaflush is a medical device that received FDA 510(k) clearance on 2022-07-20. It is manufactured by Pentaferte Italia S.R.L.. The 510(k) number is K214080.

When was Pentaflush approved by the FDA?

Pentaflush received FDA 510(k) clearance on 2022-07-20, under approval number K214080.

What company makes Pentaflush?

Pentaflush is manufactured by Pentaferte Italia S.R.L..

What is the FDA product code for Pentaflush?

The FDA product code for Pentaflush is NGT.

Other Devices by Pentaferte Italia S.R.L.

K161141ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT K211661ENFit enteral syringes (NUTRIFIT)

Related Devices (Code: NGT)

K1534810.9% Sodium Chloride Injection, USP BD PosiFlush SF SyringeBecton, Dickinson and Company K171109Praxiject 0.9% NaClMedxl, Inc. K1615520.9% Sodium Chloride Injection, USP BD PosiFlush SP SyringeBecton, Dickinson and Company K1733480.9% Sodium Chloride Injection, USPMedline Industries, Inc. K1913780.9% Sodium Chloride Injection, USP, Pre-filled COP SyringeMedline Industries, Inc. K183473AMSafe(R) Pre-Filled Normal Saline Flush SyringeAmsino International, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.