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FDA 510(k)

EXEL BUTTERFLY SCALP VEIN SET

K-Number: K020189 · 2003-03-27

ApplicantExelint International, Co.
Decision Date2003-03-27
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EXEL BUTTERFLY SCALP VEIN SET is the device name listed in this FDA 510(k) record. The listed applicant is Exelint International, Co.. It received FDA 510(k) clearance on 2003-03-27 under 510(k) number K020189. 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 EXEL BUTTERFLY SCALP VEIN SET?

EXEL BUTTERFLY SCALP VEIN SET is a medical device that received FDA 510(k) clearance on 2003-03-27. The listed applicant is Exelint International, Co.. The 510(k) number is K020189.

When did EXEL BUTTERFLY SCALP VEIN SET receive FDA 510(k) clearance?

EXEL BUTTERFLY SCALP VEIN SET received FDA 510(k) clearance on 2003-03-27, under 510(k) number K020189.

Who is the listed applicant for EXEL BUTTERFLY SCALP VEIN SET?

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

What is the FDA product code for EXEL BUTTERFLY SCALP VEIN SET?

The FDA product code for EXEL BUTTERFLY SCALP VEIN SET is FPA.

Related Clinical Trials

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Other records listing Exelint International, 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.

K251089EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic NeedleK101309EXELINT ALUMINUM HUB BLUNT NEEDLESK010197EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SETK003627EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SETK001496A.V. FISTULA NEEDLE

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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