FDA 510(k)

VPS Rhythm DLX Device with TipTracker Technology

Numéro K : K220363 · 2022-08-22

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

Date de décision2022-08-22

Code produitLJS

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

VPS Rhythm DLX Device with TipTracker Technology is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, LLC (A subsidiary of Teleflex, Inc.). It received FDA 510(k) clearance on 2022-08-22 under 510(k) number K220363. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is Arrow International, LLC (A subsidiary of Teleflex, Inc.). The 510(k) number is K220363.

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

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

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

The FDA 510(k) record lists Arrow International, LLC (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 DLX Device with TipTracker Technology?

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

Essais cliniques associés

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Autres dossiers indiquant Arrow International, LLC (A subsidiary of Teleflex, Inc.) en tant que demandeur

K243599Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)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)K220280Arrow Stiffening Stylet

Dispositifs connexes (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.

Source officielle

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