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FDA 510(k)

TFX MEDICAL INTRODUCER ASSEMBLY

K-Number: K993191 · 2000-03-24

ApplicantTfx Medical, Inc.
Decision Date2000-03-24
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TFX MEDICAL INTRODUCER ASSEMBLY is the device name listed in this FDA 510(k) record. The listed applicant is Tfx Medical, Inc.. It received FDA 510(k) clearance on 2000-03-24 under 510(k) number K993191. 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 TFX MEDICAL INTRODUCER ASSEMBLY?

TFX MEDICAL INTRODUCER ASSEMBLY is a medical device that received FDA 510(k) clearance on 2000-03-24. The listed applicant is Tfx Medical, Inc.. The 510(k) number is K993191.

When did TFX MEDICAL INTRODUCER ASSEMBLY receive FDA 510(k) clearance?

TFX MEDICAL INTRODUCER ASSEMBLY received FDA 510(k) clearance on 2000-03-24, under 510(k) number K993191.

Who is the listed applicant for TFX MEDICAL INTRODUCER ASSEMBLY?

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

What is the FDA product code for TFX MEDICAL INTRODUCER ASSEMBLY?

The FDA product code for TFX MEDICAL INTRODUCER ASSEMBLY is DYB.

Related Clinical Trials

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Other records listing Tfx Medical, Inc. 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.

K021034MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCERK020985MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCERK000665TFX MEDICAL SAFETY NEEDLE WITH 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

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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