FDA 510(k)

PLPT LDV (Low Dead Volume) Sterile Syringe

K-Number: K210443 · 2021-02-16

Decision Date2021-02-16

Product CodeQNQ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PLPT LDV (Low Dead Volume) Sterile Syringe is a medical device manufactured by Poonglim Pharmatech, Inc.. It received FDA 510(k) clearance on 2021-02-16 under approval number K210443. The device is classified under product code QNQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLPT LDV (Low Dead Volume) Sterile Syringe?

PLPT LDV (Low Dead Volume) Sterile Syringe is a medical device that received FDA 510(k) clearance on 2021-02-16. It is manufactured by Poonglim Pharmatech, Inc.. The 510(k) number is K210443.

When was PLPT LDV (Low Dead Volume) Sterile Syringe approved by the FDA?

PLPT LDV (Low Dead Volume) Sterile Syringe received FDA 510(k) clearance on 2021-02-16, under approval number K210443.

What company makes PLPT LDV (Low Dead Volume) Sterile Syringe?

PLPT LDV (Low Dead Volume) Sterile Syringe is manufactured by Poonglim Pharmatech, Inc..

What is the FDA product code for PLPT LDV (Low Dead Volume) Sterile Syringe?

The FDA product code for PLPT LDV (Low Dead Volume) Sterile Syringe is QNQ.

Other Devices by Poonglim Pharmatech, Inc.

K172483Kopac Sterile Needle K192222EZ-Inject Single use Needle K210444EZ-Injec LDV Sterile Safety Needle K221860PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe K241190PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe

Related Devices (Code: QNQ)

K213013Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV SyringeJeil Tech Co., Ltd. K220083LDV((Low Dead Volume )SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. K221860PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile SyringePoonglim Pharmatech, Inc. K213010FEELject LDV (Low dead volume) syringeFeeltech Co., Ltd. K242291SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable NeedleSol-Millennium Medical, Inc. K232943Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space SyringeSmiths Medical Asd, 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.