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FDA 510(k)

COAXIAL INTRODUCER SET

K-Number: K101399 · 2010-06-17

ApplicantMartech Medical Products
Decision Date2010-06-17
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COAXIAL INTRODUCER SET is the device name listed in this FDA 510(k) record. The listed applicant is Martech Medical Products. It received FDA 510(k) clearance on 2010-06-17 under 510(k) number K101399. 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 COAXIAL INTRODUCER SET?

COAXIAL INTRODUCER SET is a medical device that received FDA 510(k) clearance on 2010-06-17. The listed applicant is Martech Medical Products. The 510(k) number is K101399.

When did COAXIAL INTRODUCER SET receive FDA 510(k) clearance?

COAXIAL INTRODUCER SET received FDA 510(k) clearance on 2010-06-17, under 510(k) number K101399.

Who is the listed applicant for COAXIAL INTRODUCER SET?

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

What is the FDA product code for COAXIAL INTRODUCER SET?

The FDA product code for COAXIAL INTRODUCER SET is DYB.

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Other records listing Martech Medical Products 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.

K25409525G Huber NeedleK130855PTFE SUPER SHEATH INTRODUCERK120617PTFE SUPER SHEATH INTRODUCER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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