FDA 510(k)

PLACEMENT-PLUS

K-Number: K003642 · 2000-12-20

Decision Date2000-12-20

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PLACEMENT-PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Catheter Innovations, Inc.. It received FDA 510(k) clearance on 2000-12-20 under 510(k) number K003642. 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 PLACEMENT-PLUS?

PLACEMENT-PLUS is a medical device that received FDA 510(k) clearance on 2000-12-20. The listed applicant is Catheter Innovations, Inc.. The 510(k) number is K003642.

When did PLACEMENT-PLUS receive FDA 510(k) clearance?

PLACEMENT-PLUS received FDA 510(k) clearance on 2000-12-20, under 510(k) number K003642.

Who is the listed applicant for PLACEMENT-PLUS?

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

What is the FDA product code for PLACEMENT-PLUS?

The FDA product code for PLACEMENT-PLUS is LJS.

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Other records listing Catheter Innovations, Inc. as applicant

K021704VAXCEL PICC WITH PASV VALVE TECHNOLOGY K010349DUAL LUMEN MIDLINE CATHETER K993860CATHETER INNOVATIONS IMPLANTABLE PORT K991897CATHETER INNOVATIONS IMPLANTABLE PORT K981382PASV DUAL LUMEN PERIPHERALLY INSERTED MIDLINE CATHETER MODEL NUMBER MIDLINE-NUMEROUS K981368PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.