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FDA 510(k)

EXCEL PRIMARY SOLUTION SET

K-Number: K031500 · 2003-07-25

ApplicantExelint Intl. Co.
Decision Date2003-07-25
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EXCEL PRIMARY SOLUTION SET is the device name listed in this FDA 510(k) record. The listed applicant is Exelint Intl. Co.. It received FDA 510(k) clearance on 2003-07-25 under 510(k) number K031500. 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 EXCEL PRIMARY SOLUTION SET?

EXCEL PRIMARY SOLUTION SET is a medical device that received FDA 510(k) clearance on 2003-07-25. The listed applicant is Exelint Intl. Co.. The 510(k) number is K031500.

When did EXCEL PRIMARY SOLUTION SET receive FDA 510(k) clearance?

EXCEL PRIMARY SOLUTION SET received FDA 510(k) clearance on 2003-07-25, under 510(k) number K031500.

Who is the listed applicant for EXCEL PRIMARY SOLUTION SET?

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

What is the FDA product code for EXCEL PRIMARY SOLUTION SET?

The FDA product code for EXCEL PRIMARY SOLUTION SET is FPA.

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Other records listing Exelint Intl. Co. 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.

K092172EXEL I.V. EXTENSION SETK052103EXEL SECURE TOUCH II SAFETY SYRINGEK011754EXEL SECURETOUCH PTP SYRINGEK020533EXEL VACULET BLOOD COLLECTION SETK022406EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SETK011757EXEL COMFORTPOINT INSULIN PEN NEEDLE

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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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