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FDA 510(k)

VPS Rhythm Device with TipTracker Technology

K-Number: K160925 · 2016-12-22

ApplicantArrow International, Inc. (A Subsidiary of Teleflex, Inc.)
Decision Date2016-12-22
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VPS Rhythm Device with TipTracker Technology is a medical device manufactured by Arrow International, Inc. (A Subsidiary of Teleflex, Inc.). It received FDA 510(k) clearance on 2016-12-22 under approval number K160925. 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 Device with TipTracker Technology?

VPS Rhythm Device with TipTracker Technology is a medical device that received FDA 510(k) clearance on 2016-12-22. It is manufactured by Arrow International, Inc. (A Subsidiary of Teleflex, Inc.). The 510(k) number is K160925.

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

VPS Rhythm Device with TipTracker Technology received FDA 510(k) clearance on 2016-12-22, under approval number K160925.

What company makes VPS Rhythm Device with TipTracker Technology?

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

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

The FDA product code for VPS Rhythm 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)

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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.

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