FDA 510(k)

Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)

Numéro K : K243599 · 2025-03-14

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

Date de décision2025-03-14

Code produitFOZ

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) 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 2025-03-14 under 510(k) number K243599. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)?

Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) is a medical device that received FDA 510(k) clearance on 2025-03-14. The listed applicant is Arrow International, LLC (A subsidiary of Teleflex, Inc.). The 510(k) number is K243599.

When did Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) receive FDA 510(k) clearance?

Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) received FDA 510(k) clearance on 2025-03-14, under 510(k) number K243599.

Who is the listed applicant for Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)?

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 Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)?

The FDA product code for Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) is FOZ.

Essais cliniques associés

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

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 K220363VPS Rhythm DLX Device with TipTracker Technology

Dispositifs connexes (Code : FOZ)

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Source officielle

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