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FDA 510(k)

POLYFIN QR SUBCUTANEOUS INFUSION SET

K-Number: K954969 · 1996-02-22

ApplicantMedtronic Minimed
Decision Date1996-02-22
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POLYFIN QR SUBCUTANEOUS INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Minimed. It received FDA 510(k) clearance on 1996-02-22 under 510(k) number K954969. 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 POLYFIN QR SUBCUTANEOUS INFUSION SET?

POLYFIN QR SUBCUTANEOUS INFUSION SET is a medical device that received FDA 510(k) clearance on 1996-02-22. The listed applicant is Medtronic Minimed. The 510(k) number is K954969.

When did POLYFIN QR SUBCUTANEOUS INFUSION SET receive FDA 510(k) clearance?

POLYFIN QR SUBCUTANEOUS INFUSION SET received FDA 510(k) clearance on 1996-02-22, under 510(k) number K954969.

Who is the listed applicant for POLYFIN QR SUBCUTANEOUS INFUSION SET?

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

What is the FDA product code for POLYFIN QR SUBCUTANEOUS INFUSION SET?

The FDA product code for POLYFIN QR SUBCUTANEOUS INFUSION SET is FPA.

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Other records listing Medtronic Minimed 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.

K261962SmartGuard Technology; Predictive Low Glucose TechnologyK253701SmartGuard Technology; Predictive Low Glucose TechnologyK253512MiniMed Go AppK242775InPen System App (MMT-8060 (iOS), MMT-8061 (Android))K241622Extended Reservoir; MiniMed ReservoirK160860MiniMed Quick-serter

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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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