FDA 510(k)

ARROW PICC POWERED BY ARROW VPS STYLET

K-Number: K121941 · 2012-09-07

ApplicantArrow International (Subsidiary of Teleflex Inc.)

Decision Date2012-09-07

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ARROW PICC POWERED BY ARROW VPS STYLET is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International (Subsidiary of Teleflex Inc.). It received FDA 510(k) clearance on 2012-09-07 under 510(k) number K121941. 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 ARROW PICC POWERED BY ARROW VPS STYLET?

ARROW PICC POWERED BY ARROW VPS STYLET is a medical device that received FDA 510(k) clearance on 2012-09-07. The listed applicant is Arrow International (Subsidiary of Teleflex Inc.). The 510(k) number is K121941.

When did ARROW PICC POWERED BY ARROW VPS STYLET receive FDA 510(k) clearance?

ARROW PICC POWERED BY ARROW VPS STYLET received FDA 510(k) clearance on 2012-09-07, under 510(k) number K121941.

Who is the listed applicant for ARROW PICC POWERED BY ARROW VPS STYLET?

The FDA 510(k) record lists Arrow International (Subsidiary of Teleflex Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARROW PICC POWERED BY ARROW VPS STYLET?

The FDA product code for ARROW PICC POWERED BY ARROW VPS STYLET is LJS.

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Other records listing Arrow International (Subsidiary of Teleflex Inc.) as applicant

K132133CG+ ARROW JACC POWERED BY ARROW VPS STYLET K122854ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER K121501ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC)K122545CG+ ARROW PICC POWERED BY ARROW VPS STYLET K112896ARRW EVOLUTION

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.