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FDA 510(k)

VALVED TEARAWAY INTRODUCER GENERATION II

K-Number: K124046 · 2013-06-03

ApplicantMedical Components, Inc.
Decision Date2013-06-03
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VALVED TEARAWAY INTRODUCER GENERATION II is the device name listed in this FDA 510(k) record. The listed applicant is Medical Components, Inc.. It received FDA 510(k) clearance on 2013-06-03 under 510(k) number K124046. 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 VALVED TEARAWAY INTRODUCER GENERATION II?

VALVED TEARAWAY INTRODUCER GENERATION II is a medical device that received FDA 510(k) clearance on 2013-06-03. The listed applicant is Medical Components, Inc.. The 510(k) number is K124046.

When did VALVED TEARAWAY INTRODUCER GENERATION II receive FDA 510(k) clearance?

VALVED TEARAWAY INTRODUCER GENERATION II received FDA 510(k) clearance on 2013-06-03, under 510(k) number K124046.

Who is the listed applicant for VALVED TEARAWAY INTRODUCER GENERATION II?

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

What is the FDA product code for VALVED TEARAWAY INTRODUCER GENERATION II?

The FDA product code for VALVED TEARAWAY INTRODUCER GENERATION II is DYB.

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Other records listing Medical Components, Inc. as applicant

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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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