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FDA 510(k)

NAMIC Dilator and Sheath

K-Number: K253526 · 2026-07-29

ApplicantMedline Industries, LP
Decision Date2026-07-29
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NAMIC Dilator and Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, LP. It received FDA 510(k) clearance on 2026-07-29 under 510(k) number K253526. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAMIC Dilator and Sheath?

NAMIC Dilator and Sheath is a medical device that received FDA 510(k) clearance on 2026-07-29. The listed applicant is Medline Industries, LP. The 510(k) number is K253526.

When did NAMIC Dilator and Sheath receive FDA 510(k) clearance?

NAMIC Dilator and Sheath received FDA 510(k) clearance on 2026-07-29, under 510(k) number K253526.

Who is the listed applicant for NAMIC Dilator and Sheath?

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

What is the FDA product code for NAMIC Dilator and Sheath?

The FDA product code for NAMIC Dilator and Sheath is DYB.

Other records listing Medline Industries, LP as applicant

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Related Devices (Code: DYB)

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.

K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLCK254248Introducer Sheath SetCardiocycle Medical(Suzhou) Co., 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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