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FDA 510(k)

AMECO SHEATH INTRODUCER

K-Number: K131144 · 2013-08-15

ApplicantAmeco Medical Industries
Decision Date2013-08-15
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMECO SHEATH INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Ameco Medical Industries. It received FDA 510(k) clearance on 2013-08-15 under 510(k) number K131144. 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 AMECO SHEATH INTRODUCER?

AMECO SHEATH INTRODUCER is a medical device that received FDA 510(k) clearance on 2013-08-15. The listed applicant is Ameco Medical Industries. The 510(k) number is K131144.

When did AMECO SHEATH INTRODUCER receive FDA 510(k) clearance?

AMECO SHEATH INTRODUCER received FDA 510(k) clearance on 2013-08-15, under 510(k) number K131144.

Who is the listed applicant for AMECO SHEATH INTRODUCER?

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

What is the FDA product code for AMECO SHEATH INTRODUCER?

The FDA product code for AMECO SHEATH INTRODUCER is DYB.

Related Clinical Trials

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.

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Other records listing Ameco Medical Industries 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.

K152819Amecath Peripheral inserted Central Venous Catheter SetsK131814AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETERK123943AMECATH DUAL LUMEN HEMODIALYSIS CATHETERK110794AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITSK110793AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS

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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