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FDA 510(k)

INTRODUCER, PERCUTANEOUS SELDINGER

K-Number: K812964 · 1981-11-16

ApplicantTriad Medical Division
Decision Date1981-11-16
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTRODUCER, PERCUTANEOUS SELDINGER is the device name listed in this FDA 510(k) record. The listed applicant is Triad Medical Division. It received FDA 510(k) clearance on 1981-11-16 under 510(k) number K812964. 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, PERCUTANEOUS SELDINGER?

INTRODUCER, PERCUTANEOUS SELDINGER is a medical device that received FDA 510(k) clearance on 1981-11-16. The listed applicant is Triad Medical Division. The 510(k) number is K812964.

When did INTRODUCER, PERCUTANEOUS SELDINGER receive FDA 510(k) clearance?

INTRODUCER, PERCUTANEOUS SELDINGER received FDA 510(k) clearance on 1981-11-16, under 510(k) number K812964.

Who is the listed applicant for INTRODUCER, PERCUTANEOUS SELDINGER?

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

What is the FDA product code for INTRODUCER, PERCUTANEOUS SELDINGER?

The FDA product code for INTRODUCER, PERCUTANEOUS SELDINGER is DYB.

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Other records listing Triad Medical Division 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.

K840391ANGIOGRAPHIC PROCEDURE TRAYK831287E-Z FITK823054DRAPE, SURGICAL ANGIOGRAPHY

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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