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FDA 510(k)

PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318

K-Number: K001832 · 2000-08-18

ApplicantMinimed, Inc.
Decision Date2000-08-18
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318 is the device name listed in this FDA 510(k) record. The listed applicant is Minimed, Inc.. It received FDA 510(k) clearance on 2000-08-18 under 510(k) number K001832. 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 PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318?

PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318 is a medical device that received FDA 510(k) clearance on 2000-08-18. The listed applicant is Minimed, Inc.. The 510(k) number is K001832.

When did PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318 receive FDA 510(k) clearance?

PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318 received FDA 510(k) clearance on 2000-08-18, under 510(k) number K001832.

Who is the listed applicant for PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318?

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

What is the FDA product code for PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318?

The FDA product code for PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318 is FPA.

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Other records listing Minimed, Inc. 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.

K031541PARADIGMPAL, MODEL MMT-7330K031390MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712K030531MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METERK021974MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311K010377MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385K001828PARADIGM 1.5ML RESERVOIR, MODEL 326

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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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