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FDA 510(k)

MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP

K-Number: K041317 · 2004-07-19

ApplicantMedtronic Minimed
Decision Date2004-07-19
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Minimed. It received FDA 510(k) clearance on 2004-07-19 under 510(k) number K041317. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP?

MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP is a medical device that received FDA 510(k) clearance on 2004-07-19. The listed applicant is Medtronic Minimed. The 510(k) number is K041317.

When did MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP receive FDA 510(k) clearance?

MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP received FDA 510(k) clearance on 2004-07-19, under 510(k) number K041317.

Who is the listed applicant for MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP?

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 MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP?

The FDA product code for MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP is LZG.

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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: LZG)

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.

K262153Pivot Insulin Delivery SystemModular Medical, Inc.K253534Pivot Insulin Delivery SystemModular MedicalK240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc.K241622Extended Reservoir; MiniMed ReservoirMedtronic MinimedK223372Omnipod GO Insulin Delivery DeviceInsulet CorporationK210714Extended ReservoirMedtronic Minimed, Inc.

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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