FDA 510(k)

VPS Rhythm Device with TipTracker Technology

Номер K: K160925 · 2016-12-22

ЗаявительArrow International, Inc. (A Subsidiary of Teleflex, Inc.)

Дата решения2016-12-22

Код продуктаLJS

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

VPS Rhythm Device with TipTracker Technology is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, Inc. (A Subsidiary of Teleflex, Inc.). It received FDA 510(k) clearance on 2016-12-22 under 510(k) number K160925. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

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. The listed applicant is Arrow International, Inc. (A Subsidiary of Teleflex, Inc.). The 510(k) number is K160925.

When did VPS Rhythm Device with TipTracker Technology receive FDA 510(k) clearance?

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

Who is the listed applicant for VPS Rhythm Device with TipTracker Technology?

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

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: 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.

Официальный источник

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