FDA 510(k)

FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH

K-Number: K050889 · 2005-08-26

Decision Date2005-08-26

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Crs Medical Diagnostics, Inc.. It received FDA 510(k) clearance on 2005-08-26 under 510(k) number K050889. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH?

FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH is a medical device that received FDA 510(k) clearance on 2005-08-26. The listed applicant is Crs Medical Diagnostics, Inc.. The 510(k) number is K050889.

When did FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH receive FDA 510(k) clearance?

FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH received FDA 510(k) clearance on 2005-08-26, under 510(k) number K050889.

Who is the listed applicant for FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH?

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

What is the FDA product code for FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH?

The FDA product code for FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH is LJS.

Related Clinical Trials

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Other records listing Crs Medical Diagnostics, Inc. as applicant

K072518CRS FIBRIN ANALYSIS CATHETER TESTING SYSTEM (FACTS)

Related Devices (Code: LJS)

K260929Neonav ECG Tip Location SystemNavi Medical Technologies K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve TechnologySpectrum Vascular K252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc.K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); HydrAccess Vascular, Inc.K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)Access Vascular, Inc.K243484PM2+ System and SmartPICC StyletPiccolo Medical, Inc.

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.