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FDA 510(k)

TFX MEDICAL INTRODUCER KIT

K-Number: K991647 · 2000-01-04

ApplicantTfx Medical Group
Decision Date2000-01-04
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TFX MEDICAL INTRODUCER KIT is the device name listed in this FDA 510(k) record. The listed applicant is Tfx Medical Group. It received FDA 510(k) clearance on 2000-01-04 under 510(k) number K991647. 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 KIT?

TFX MEDICAL INTRODUCER KIT is a medical device that received FDA 510(k) clearance on 2000-01-04. The listed applicant is Tfx Medical Group. The 510(k) number is K991647.

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

TFX MEDICAL INTRODUCER KIT received FDA 510(k) clearance on 2000-01-04, under 510(k) number K991647.

Who is the listed applicant for TFX MEDICAL INTRODUCER KIT?

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

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

The FDA product code for TFX MEDICAL INTRODUCER KIT 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Tfx Medical Group 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.

K992664TFX MEDICAL STYLET CATHETERK963320TFX MEDICAL GUIDEWIRE

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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