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FDA 510(k)

ProntoPump Sterile Tube Set

K-Number: K200893 · 2021-05-04

ApplicantIpax, Inc.
Decision Date2021-05-04
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ProntoPump Sterile Tube Set is the device name listed in this FDA 510(k) record. The listed applicant is Ipax, Inc.. It received FDA 510(k) clearance on 2021-05-04 under 510(k) number K200893. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProntoPump Sterile Tube Set?

ProntoPump Sterile Tube Set is a medical device that received FDA 510(k) clearance on 2021-05-04. The listed applicant is Ipax, Inc.. The 510(k) number is K200893.

When did ProntoPump Sterile Tube Set receive FDA 510(k) clearance?

ProntoPump Sterile Tube Set received FDA 510(k) clearance on 2021-05-04, under 510(k) number K200893.

Who is the listed applicant for ProntoPump Sterile Tube Set?

The FDA 510(k) record lists Ipax, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ProntoPump Sterile Tube Set?

The FDA product code for ProntoPump Sterile Tube Set is LHI.

Related Devices (Code: LHI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252987ADRx™ Admixture DeviceEpic Medical Pte. , Ltd.K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345Medline Bag DecanterMedline Industries, LPK251715FlowArt® Vial Access Device VentedAsset MedikalK251676Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)Microtek Medical, LLCK243404HyHub™ and HyHub™ Duo Vial Access DevicesTakeda Pharmaceuticals

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.

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