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FDA 510(k)

Steripath Micro Blood Collection System

K-Number: K200661 · 2020-10-08

ApplicantMagnolia Medical Technologies, Inc.
Decision Date2020-10-08
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Steripath Micro 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 2020-10-08 under 510(k) number K200661. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Steripath Micro Blood Collection System?

Steripath Micro Blood Collection System is a medical device that received FDA 510(k) clearance on 2020-10-08. The listed applicant is Magnolia Medical Technologies, Inc.. The 510(k) number is K200661.

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

Steripath Micro Blood Collection System received FDA 510(k) clearance on 2020-10-08, under 510(k) number K200661.

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

The FDA product code for Steripath Micro Blood Collection System is FPA.

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 SystemK192247Steripath Gen2 Blood Collection System

Related Devices (Code: FPA)

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.

K261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)K251814EZ™ IV Administration SetEpic Medical Pte. , Ltd.

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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