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FDA 510(k)

ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT

K-Number: K040446 · 2004-03-05

ApplicantAngioDynamics, Inc.
Decision Date2004-03-05
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT is the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 2004-03-05 under 510(k) number K040446. 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 ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT?

ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT is a medical device that received FDA 510(k) clearance on 2004-03-05. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K040446.

When did ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT receive FDA 510(k) clearance?

ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT received FDA 510(k) clearance on 2004-03-05, under 510(k) number K040446.

Who is the listed applicant for ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT?

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

What is the FDA product code for ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT?

The FDA product code for ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT is LJS.

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Related Devices (Code: LJS)

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K260929Neonav ECG Tip Location SystemNavi Medical TechnologiesK252373BioFlo 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 VascularK252792PM2™ 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

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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