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FDA 510(k)

MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385

K-Number: K010377 · 2001-04-05

ApplicantMinimed, Inc.
Decision Date2001-04-05
Product CodeKZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385 is the device name listed in this FDA 510(k) record. The listed applicant is Minimed, Inc.. It received FDA 510(k) clearance on 2001-04-05 under 510(k) number K010377. 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 MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385?

MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385 is a medical device that received FDA 510(k) clearance on 2001-04-05. The listed applicant is Minimed, Inc.. The 510(k) number is K010377.

When did MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385 receive FDA 510(k) clearance?

MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385 received FDA 510(k) clearance on 2001-04-05, under 510(k) number K010377.

Who is the listed applicant for MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385?

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 MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385?

The FDA product code for MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385 is KZH.

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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 7311K001827PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325K001828PARADIGM 1.5ML RESERVOIR, MODEL 326

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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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