FDA 510(k)

VPS Rhythm Device with TipTracker Technology

K-Nummer: K160925 · 2016-12-22

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

Entscheidungsdatum2016-12-22

ProduktcodeLJS

BeratungsausschussHO

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

Zugehörige klinische Studien

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

NCT07608549FLASH Pilot Phase 1 SicherheitstudieNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Künstlich-intelligenz-assistiertes Uro-Cam Katheter-Assessment-System zur Diagnose von BlasenkrebsNOT_YET_RECRUITING

Verwandte Geräte (Code: LJS)

K260929Neonav ECG Tip Location SystemNavi Medical Technologies K252373BioFlo Hybrid PICC mit ENDEXO-Technologie und PASV-Ventiltechnologie; BioFlo PICC mit ENDEXO-Technologie und PASV-Ventiltechnologie; BioFlo PICC mit ENDEXO-Technologie; BioFlo Midline Katheter; Xcela Power Injectable PICC; Xcela PICC mit PASV-Ventiltechnologie; Xcela Hybrid PICC mit PASV-VentiltechnologieSpectrum 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 Katheter (PICC-251CM) (PICC-251CM); Dual-Lumen 5Fr HydroPICC Katheter (PICC-252CM) (PICC-252CM)Access Vascular, Inc.K243484PM2+ System and SmartPICC StyletPiccolo Medical, Inc.

Offizielle Quelle

In der FDA-Datenbank anzeigen →

Daten aus der FDA Open API. Für die aktuellsten und verbindlichen Informationen konsultieren Sie bitte stets den offiziellen Datensatz.