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FDA 510(k)

PVC FREE INTRAVASCULAR ADMINISTRATION SET

K-Number: K011216 · 2001-07-18

ApplicantBiometrix , Ltd.
Decision Date2001-07-18
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PVC FREE INTRAVASCULAR ADMINISTRATION SET is the device name listed in this FDA 510(k) record. The listed applicant is Biometrix , Ltd.. It received FDA 510(k) clearance on 2001-07-18 under 510(k) number K011216. 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 PVC FREE INTRAVASCULAR ADMINISTRATION SET?

PVC FREE INTRAVASCULAR ADMINISTRATION SET is a medical device that received FDA 510(k) clearance on 2001-07-18. The listed applicant is Biometrix , Ltd.. The 510(k) number is K011216.

When did PVC FREE INTRAVASCULAR ADMINISTRATION SET receive FDA 510(k) clearance?

PVC FREE INTRAVASCULAR ADMINISTRATION SET received FDA 510(k) clearance on 2001-07-18, under 510(k) number K011216.

Who is the listed applicant for PVC FREE INTRAVASCULAR ADMINISTRATION SET?

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

What is the FDA product code for PVC FREE INTRAVASCULAR ADMINISTRATION SET?

The FDA product code for PVC FREE INTRAVASCULAR ADMINISTRATION SET is FPA.

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Other records listing Biometrix , Ltd. 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.

K001461TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SETK925040TELEPULSE

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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