FDA 510(k)

Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts

Numéro K : K260105 · 2026-06-05

Date de décision2026-06-05

Code produitDXC

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences. It received FDA 510(k) clearance on 2026-06-05 under 510(k) number K260105. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts?

Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts is a medical device that received FDA 510(k) clearance on 2026-06-05. The listed applicant is Edwards Lifesciences. The 510(k) number is K260105.

When did Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts receive FDA 510(k) clearance?

Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts received FDA 510(k) clearance on 2026-06-05, under 510(k) number K260105.

Who is the listed applicant for Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts?

The FDA 510(k) record lists Edwards Lifesciences as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts?

The FDA product code for Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts is DXC.

Essais cliniques associés

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Autres dossiers indiquant Edwards Lifesciences en tant que demandeur

K254232ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150)K254279Edwards eSheath+ introducer set K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)K253034HemoSphere Stream Module K252364Edwards eSheath Optima introducer set K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2)

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Source officielle

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