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FDA 510(k)

MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300

K-Number: K970479 · 1997-03-31

ApplicantMedtronic Minimed
Decision Date1997-03-31
Product CodeKZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Minimed. It received FDA 510(k) clearance on 1997-03-31 under 510(k) number K970479. The device is classified under product code KZH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300?

MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300 is a medical device that received FDA 510(k) clearance on 1997-03-31. The listed applicant is Medtronic Minimed. The 510(k) number is K970479.

When did MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300 receive FDA 510(k) clearance?

MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300 received FDA 510(k) clearance on 1997-03-31, under 510(k) number K970479.

Who is the listed applicant for MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300?

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 MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300?

The FDA product code for MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300 is KZH.

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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: KZH)

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.

K243232GripMateSynthon Hispania S.L.K213429AccuSert Needle InserterEmed Technologies CorporationK163400Orbit InserterYpsomed AGK160860MiniMed Quick-serterMedtronic MinimedK124026LOBSTER AUTO-INJECTORScandinavian Health LimitedK122837AUTOJECT 2 FOR GLASSY SYRINGEOwen Mumford, Ltd.

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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