FDA 510(k)

XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY

K-Number: K111906 · 2011-07-29

Decision Date2011-07-29

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY is the device name listed in this FDA 510(k) record. The listed applicant is Navilyst Medical, Inc.. It received FDA 510(k) clearance on 2011-07-29 under 510(k) number K111906. 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 XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY?

XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY is a medical device that received FDA 510(k) clearance on 2011-07-29. The listed applicant is Navilyst Medical, Inc.. The 510(k) number is K111906.

When did XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY receive FDA 510(k) clearance?

XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY received FDA 510(k) clearance on 2011-07-29, under 510(k) number K111906.

Who is the listed applicant for XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY?

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

What is the FDA product code for XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY?

The FDA product code for XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY 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.