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FDA 510(k)

WINGED INFUSION SET

K-Number: K832622 · 1983-10-14

ApplicantTop Surgical Manufacturers Co.
Decision Date1983-10-14
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

WINGED INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Top Surgical Manufacturers Co.. It received FDA 510(k) clearance on 1983-10-14 under 510(k) number K832622. 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 WINGED INFUSION SET?

WINGED INFUSION SET is a medical device that received FDA 510(k) clearance on 1983-10-14. The listed applicant is Top Surgical Manufacturers Co.. The 510(k) number is K832622.

When did WINGED INFUSION SET receive FDA 510(k) clearance?

WINGED INFUSION SET received FDA 510(k) clearance on 1983-10-14, under 510(k) number K832622.

Who is the listed applicant for WINGED INFUSION SET?

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

What is the FDA product code for WINGED INFUSION SET?

The FDA product code for WINGED INFUSION 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 Top Surgical Manufacturers 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.

K844343TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPEK843415TOP HYPODERMIC SYRINGE LUER LOCKK843313TOP DISPOSABLE SPINAL NEEDLEK843414TOP HYPODERMIC SYRINGE PISTONK841119TOPS DISPOS. INFUSION SET/HEMODIALYSISK841025TOP DISPOSABLE INFUSION SET

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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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