FDA 510(k)

CATHETER INSERTION TRAY

K-Number: K962849 · 1996-10-07

Decision Date1996-10-07

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

CATHETER INSERTION TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Medcare Medical Group, Inc.. It received FDA 510(k) clearance on 1996-10-07 under 510(k) number K962849. 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 CATHETER INSERTION TRAY?

CATHETER INSERTION TRAY is a medical device that received FDA 510(k) clearance on 1996-10-07. The listed applicant is Medcare Medical Group, Inc.. The 510(k) number is K962849.

When did CATHETER INSERTION TRAY receive FDA 510(k) clearance?

CATHETER INSERTION TRAY received FDA 510(k) clearance on 1996-10-07, under 510(k) number K962849.

Who is the listed applicant for CATHETER INSERTION TRAY?

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

What is the FDA product code for CATHETER INSERTION TRAY?

The FDA product code for CATHETER INSERTION TRAY is LJS.

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.

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Other records listing Medcare Medical Group, Inc. as applicant

K973497HUBERLOC K970152BIOPSY TRAY K961075MEDCARE REGIONAL ANETHESIA KIT K962328SINGLE USE INSTRUMENT TRAY K962527GENERAL PURPOSE DENTAL TRAY K961880MEDCARE SUCTION CONNECTING TUBING

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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.