FDA 510(k)

Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating

Numéro K : K241553 · 2024-06-27

Date de décision2024-06-27

Code produitMCW

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating is the device name listed in this FDA 510(k) record. The listed applicant is Eximo Medical, Ltd.. It received FDA 510(k) clearance on 2024-06-27 under 510(k) number K241553. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating?

Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating is a medical device that received FDA 510(k) clearance on 2024-06-27. The listed applicant is Eximo Medical, Ltd.. The 510(k) number is K241553.

When did Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating receive FDA 510(k) clearance?

Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating received FDA 510(k) clearance on 2024-06-27, under 510(k) number K241553.

Who is the listed applicant for Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating?

The FDA 510(k) record lists Eximo Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating?

The FDA product code for Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating is MCW.

Essais cliniques associés

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Autres dossiers indiquant Eximo Medical, Ltd. en tant que demandeur

K233668Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000)K230709Auryon Atherectomy System K220116Auryon Atherectomy Catheters K221077Auryon Atherectomy System K202835Auryon Atherectomy System K181642B-Laser Atherectomy System

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Dispositifs connexes (Code : MCW)

K260244Auryon Atherectomy SystemEximo Medical K250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)Cardio Flow Inc.,K250385Turbo-Elite Laser Atherectomy CatheterSpectranetics K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow Inc.,K233483FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)Cardio Flow Inc.,

Source officielle

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