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FDA 510(k)

CONCENTRATED PLATELET ADMIN. SET

K-Number: K840212 · 1984-03-06

ApplicantAmerican Mcgaw
Decision Date1984-03-06
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CONCENTRATED PLATELET ADMIN. SET is the device name listed in this FDA 510(k) record. The listed applicant is American Mcgaw. It received FDA 510(k) clearance on 1984-03-06 under 510(k) number K840212. 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 CONCENTRATED PLATELET ADMIN. SET?

CONCENTRATED PLATELET ADMIN. SET is a medical device that received FDA 510(k) clearance on 1984-03-06. The listed applicant is American Mcgaw. The 510(k) number is K840212.

When did CONCENTRATED PLATELET ADMIN. SET receive FDA 510(k) clearance?

CONCENTRATED PLATELET ADMIN. SET received FDA 510(k) clearance on 1984-03-06, under 510(k) number K840212.

Who is the listed applicant for CONCENTRATED PLATELET ADMIN. SET?

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

What is the FDA product code for CONCENTRATED PLATELET ADMIN. SET?

The FDA product code for CONCENTRATED PLATELET ADMIN. SET is FPA.

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Other records listing American Mcgaw 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.

K853549MCGAW/DROP WATCH FLOW MONITORK843639ADD-A-VIAL SOLUTION TRANSFER DEVICEK843954MIXING CONTAINERK841729ACCUPRO ENTERAL FEEDING PUMPK840388PAB IV CONTAINERK831716CAPD - CATHETER ADAPTER

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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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure 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)

Official Source

View on FDA Database →

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

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