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FDA 510(k)

10F Sheath and Dilator Set

K-Number: K233432 · 2023-12-08

ApplicantArgon Medical Devices, Inc.
Decision Date2023-12-08
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

10F Sheath and Dilator Set is the device name listed in this FDA 510(k) record. The listed applicant is Argon Medical Devices, Inc.. It received FDA 510(k) clearance on 2023-12-08 under 510(k) number K233432. 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 10F Sheath and Dilator Set?

10F Sheath and Dilator Set is a medical device that received FDA 510(k) clearance on 2023-12-08. The listed applicant is Argon Medical Devices, Inc.. The 510(k) number is K233432.

When did 10F Sheath and Dilator Set receive FDA 510(k) clearance?

10F Sheath and Dilator Set received FDA 510(k) clearance on 2023-12-08, under 510(k) number K233432.

Who is the listed applicant for 10F Sheath and Dilator Set?

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

What is the FDA product code for 10F Sheath and Dilator Set?

The FDA product code for 10F Sheath and Dilator Set is DYB.

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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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