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FDA 510(k)

Intri24 Introducer Sheath (52-101)

K-Number: K233646 · 2023-12-12

ApplicantInari Medical, Inc.
Decision Date2023-12-12
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Intri24 Introducer Sheath (52-101) is the device name listed in this FDA 510(k) record. The listed applicant is Inari Medical, Inc.. It received FDA 510(k) clearance on 2023-12-12 under 510(k) number K233646. 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 Intri24 Introducer Sheath (52-101)?

Intri24 Introducer Sheath (52-101) is a medical device that received FDA 510(k) clearance on 2023-12-12. The listed applicant is Inari Medical, Inc.. The 510(k) number is K233646.

When did Intri24 Introducer Sheath (52-101) receive FDA 510(k) clearance?

Intri24 Introducer Sheath (52-101) received FDA 510(k) clearance on 2023-12-12, under 510(k) number K233646.

Who is the listed applicant for Intri24 Introducer Sheath (52-101)?

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

What is the FDA product code for Intri24 Introducer Sheath (52-101)?

The FDA product code for Intri24 Introducer Sheath (52-101) is DYB.

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Other records listing Inari Medical, 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.

K252508Intri26 Introducer SheathK253323Protrieve SheathK250421InThrill™ Thrombectomy SystemK250088FlowTriever2 CatheterK241894Artix™ MT; Artix™ Thin-Walled Thrombectomy SheathK242557ClotTriever XL Catheter (41-102)

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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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture 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, LLC

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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