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FDA 510(k)

RAPID SOLUTION ADMIN SET W/INTEGRAL HEAT EXCHANGER

K-Number: K854806 · 1986-02-25

ApplicantGrant Medical Center
Decision Date1986-02-25
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RAPID SOLUTION ADMIN SET W/INTEGRAL HEAT EXCHANGER is the device name listed in this FDA 510(k) record. The listed applicant is Grant Medical Center. It received FDA 510(k) clearance on 1986-02-25 under 510(k) number K854806. 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 RAPID SOLUTION ADMIN SET W/INTEGRAL HEAT EXCHANGER?

RAPID SOLUTION ADMIN SET W/INTEGRAL HEAT EXCHANGER is a medical device that received FDA 510(k) clearance on 1986-02-25. The listed applicant is Grant Medical Center. The 510(k) number is K854806.

When did RAPID SOLUTION ADMIN SET W/INTEGRAL HEAT EXCHANGER receive FDA 510(k) clearance?

RAPID SOLUTION ADMIN SET W/INTEGRAL HEAT EXCHANGER received FDA 510(k) clearance on 1986-02-25, under 510(k) number K854806.

Who is the listed applicant for RAPID SOLUTION ADMIN SET W/INTEGRAL HEAT EXCHANGER?

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

What is the FDA product code for RAPID SOLUTION ADMIN SET W/INTEGRAL HEAT EXCHANGER?

The FDA product code for RAPID SOLUTION ADMIN SET W/INTEGRAL HEAT EXCHANGER is FPA.

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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

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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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