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FDA 510(k)

CUSTOM IV SET

K-Number: K830182 · 1983-05-09

ApplicantCustom Medical, Inc.
Decision Date1983-05-09
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CUSTOM IV SET is the device name listed in this FDA 510(k) record. The listed applicant is Custom Medical, Inc.. It received FDA 510(k) clearance on 1983-05-09 under 510(k) number K830182. 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 CUSTOM IV SET?

CUSTOM IV SET is a medical device that received FDA 510(k) clearance on 1983-05-09. The listed applicant is Custom Medical, Inc.. The 510(k) number is K830182.

When did CUSTOM IV SET receive FDA 510(k) clearance?

CUSTOM IV SET received FDA 510(k) clearance on 1983-05-09, under 510(k) number K830182.

Who is the listed applicant for CUSTOM IV SET?

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

What is the FDA product code for CUSTOM IV SET?

The FDA product code for CUSTOM IV SET is FPA.

Related Clinical Trials

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.

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Other records listing Custom Medical, 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.

K905002SINGLE USE MANUAL RESUSCITATORSK832758RED COLOR-TINTED TUBING

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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