FDA 510(k)

VPS Rhythm DLX Device with TipTracker Technology

K-Number: K220363 · 2022-08-22

ApplicantArrow International, LLC (A subsidiary of Teleflex, Inc.)

Decision Date2022-08-22

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

VPS Rhythm DLX Device with TipTracker Technology is a medical device manufactured by Arrow International, LLC (A subsidiary of Teleflex, Inc.). It received FDA 510(k) clearance on 2022-08-22 under approval number K220363. 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 VPS Rhythm DLX Device with TipTracker Technology?

VPS Rhythm DLX Device with TipTracker Technology is a medical device that received FDA 510(k) clearance on 2022-08-22. It is manufactured by Arrow International, LLC (A subsidiary of Teleflex, Inc.). The 510(k) number is K220363.

When was VPS Rhythm DLX Device with TipTracker Technology approved by the FDA?

VPS Rhythm DLX Device with TipTracker Technology received FDA 510(k) clearance on 2022-08-22, under approval number K220363.

What company makes VPS Rhythm DLX Device with TipTracker Technology?

VPS Rhythm DLX Device with TipTracker Technology is manufactured by Arrow International, LLC (A subsidiary of Teleflex, Inc.).

What is the FDA product code for VPS Rhythm DLX Device with TipTracker Technology?

The FDA product code for VPS Rhythm DLX Device with TipTracker Technology is LJS.

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Related PubMed Literature

PMID: 41116086 Eye-tracking-based tablet application for enhanced cognitive assessment: a clinical trial for software as a medical device (SaMD). GeroScience (2025) PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025) PMID: 40948288 [Research on Application of Medical Device Real-World Evidence in Regulatory Decisions of the United States]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025) PMID: 40553217 Device reps in theatre: blurred boundaries or regulatory gaps? Monash bioethics review (2025)

Other Devices by Arrow International, LLC (A subsidiary of Teleflex, Inc.)

K220280Arrow Stiffening Stylet K242281Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822) K243599Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818)

Related Devices (Code: LJS)

K160925VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) K162443PowerPICC Provena CathetersC.R. Bard, Inc. K161496Turbo-Flo PICC SetsCook Incorporated K161765CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex K153469Cathtong I PICC CatheterL&Z Us, Inc. K151985PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH CatheterC.R. Bard, 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.