FDA 510(k)

SYNERGY CT PICC

K-Number: K101329 · 2010-08-19

ApplicantHealth Line International Corporation

Decision Date2010-08-19

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SYNERGY CT PICC is the device name listed in this FDA 510(k) record. The listed applicant is Health Line International Corporation. It received FDA 510(k) clearance on 2010-08-19 under 510(k) number K101329. 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 SYNERGY CT PICC?

SYNERGY CT PICC is a medical device that received FDA 510(k) clearance on 2010-08-19. The listed applicant is Health Line International Corporation. The 510(k) number is K101329.

When did SYNERGY CT PICC receive FDA 510(k) clearance?

SYNERGY CT PICC received FDA 510(k) clearance on 2010-08-19, under 510(k) number K101329.

Who is the listed applicant for SYNERGY CT PICC?

The FDA 510(k) record lists Health Line International Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNERGY CT PICC?

The FDA product code for SYNERGY CT PICC is LJS.

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Other records listing Health Line International Corporation as applicant

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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.