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FDA 510(k)

SURSHIELD WINGED INFUSION SET

K-Number: K010103 · 2001-03-15

ApplicantTerumo Medical Corp.
Decision Date2001-03-15
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURSHIELD WINGED INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 2001-03-15 under 510(k) number K010103. 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 SURSHIELD WINGED INFUSION SET?

SURSHIELD WINGED INFUSION SET is a medical device that received FDA 510(k) clearance on 2001-03-15. The listed applicant is Terumo Medical Corp.. The 510(k) number is K010103.

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

SURSHIELD WINGED INFUSION SET received FDA 510(k) clearance on 2001-03-15, under 510(k) number K010103.

Who is the listed applicant for SURSHIELD WINGED INFUSION SET?

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

What is the FDA product code for SURSHIELD WINGED INFUSION SET?

The FDA product code for SURSHIELD WINGED INFUSION SET is FPA.

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Other records listing Terumo Medical Corp. as applicant

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K111606PINNACLE PRECISION ACCESS SYSTEMK111556GLIDECROSS SUPPORT CATHETERK110540TERUMO SUPPORT CATHETERK102008GLIDESHEATHK091329PINNACLE DESTINATION PERIPHERAL GUIDING SHEATHK082997TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER

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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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