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FDA 510(k)

SURSHIELD SAFETY WINGED INFUSION SET

K-Number: K031266 · 2003-05-30

ApplicantTerumo Corp.
Decision Date2003-05-30
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURSHIELD SAFETY WINGED INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Corp.. It received FDA 510(k) clearance on 2003-05-30 under 510(k) number K031266. 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 SAFETY WINGED INFUSION SET?

SURSHIELD SAFETY WINGED INFUSION SET is a medical device that received FDA 510(k) clearance on 2003-05-30. The listed applicant is Terumo Corp.. The 510(k) number is K031266.

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

SURSHIELD SAFETY WINGED INFUSION SET received FDA 510(k) clearance on 2003-05-30, under 510(k) number K031266.

Who is the listed applicant for SURSHIELD SAFETY WINGED INFUSION SET?

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

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

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

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Other records listing Terumo Corp. 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.

K100282TERUMO SURSHIELD- PUR SAFETY I.V. CATHETERK092372HEARTRAIL III GUIDING CATHETERK091417SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527AK090973TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)K073474CAPIOX CIRCUIT CONNECTORSK071572CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

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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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