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FDA 510(k)

Introducer Sheath Kits

K-Number: K242248 · 2024-08-22

ApplicantBeijing Demax Medical Technology Co.,Ltd
Decision Date2024-08-22
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Introducer Sheath Kits is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Demax Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2024-08-22 under 510(k) number K242248. 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 Introducer Sheath Kits?

Introducer Sheath Kits is a medical device that received FDA 510(k) clearance on 2024-08-22. The listed applicant is Beijing Demax Medical Technology Co.,Ltd. The 510(k) number is K242248.

When did Introducer Sheath Kits receive FDA 510(k) clearance?

Introducer Sheath Kits received FDA 510(k) clearance on 2024-08-22, under 510(k) number K242248.

Who is the listed applicant for Introducer Sheath Kits?

The FDA 510(k) record lists Beijing Demax Medical Technology Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Introducer Sheath Kits?

The FDA product code for Introducer Sheath Kits is DYB.

Other records listing Beijing Demax Medical Technology Co.,Ltd 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.

K222184Introducer Sheath KitsK222182Radial Artery Compression Tourniquets

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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