FDA 510(k)

HR POLYURETHANE PICC AND MIDLINE CATHETERS

K-Number: K964556 · 1997-04-16

ApplicantJohnson & Johnson Medical, Inc.

Decision Date1997-04-16

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

HR POLYURETHANE PICC AND MIDLINE CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Medical, Inc.. It received FDA 510(k) clearance on 1997-04-16 under 510(k) number K964556. 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 HR POLYURETHANE PICC AND MIDLINE CATHETERS?

HR POLYURETHANE PICC AND MIDLINE CATHETERS is a medical device that received FDA 510(k) clearance on 1997-04-16. The listed applicant is Johnson & Johnson Medical, Inc.. The 510(k) number is K964556.

When did HR POLYURETHANE PICC AND MIDLINE CATHETERS receive FDA 510(k) clearance?

HR POLYURETHANE PICC AND MIDLINE CATHETERS received FDA 510(k) clearance on 1997-04-16, under 510(k) number K964556.

Who is the listed applicant for HR POLYURETHANE PICC AND MIDLINE CATHETERS?

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

What is the FDA product code for HR POLYURETHANE PICC AND MIDLINE CATHETERS?

The FDA product code for HR POLYURETHANE PICC AND MIDLINE CATHETERS is LJS.

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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.