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FDA 510(k)

Steripath Gen2 Blood Collection System

K-Number: K192247 · 2020-02-28

ApplicantMagnolia Medical Technologies, Inc.
Decision Date2020-02-28
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Steripath Gen2 Blood Collection System is the device name listed in this FDA 510(k) record. The listed applicant is Magnolia Medical Technologies, Inc.. It received FDA 510(k) clearance on 2020-02-28 under 510(k) number K192247. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Steripath Gen2 Blood Collection System?

Steripath Gen2 Blood Collection System is a medical device that received FDA 510(k) clearance on 2020-02-28. The listed applicant is Magnolia Medical Technologies, Inc.. The 510(k) number is K192247.

When did Steripath Gen2 Blood Collection System receive FDA 510(k) clearance?

Steripath Gen2 Blood Collection System received FDA 510(k) clearance on 2020-02-28, under 510(k) number K192247.

Who is the listed applicant for Steripath Gen2 Blood Collection System?

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

What is the FDA product code for Steripath Gen2 Blood Collection System?

The FDA product code for Steripath Gen2 Blood Collection System is JKA.

Other records listing Magnolia Medical Technologies, Inc. as applicant

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.

K251812Steripath® Flow™ Blood Collection SystemK222299Steripath Micro Blood Collection SystemK200661Steripath Micro Blood Collection System

Related Devices (Code: JKA)

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.

K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and CompanyK252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and CompanyK252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and CompanyK252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and CompanyK251812Steripath® Flow™ Blood Collection SystemMagnolia Medical Technologies

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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