FDA 510(k)

Vein Clamps, Artery Clamps

Numéro K : K161315 · 2016-08-18

DemandeurAros Surgical Instruments Corporation

Date de décision2016-08-18

Code produitDXC

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Vein Clamps, Artery Clamps is the device name listed in this FDA 510(k) record. The listed applicant is Aros Surgical Instruments Corporation. It received FDA 510(k) clearance on 2016-08-18 under 510(k) number K161315. 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 Vein Clamps, Artery Clamps?

Vein Clamps, Artery Clamps is a medical device that received FDA 510(k) clearance on 2016-08-18. The listed applicant is Aros Surgical Instruments Corporation. The 510(k) number is K161315.

When did Vein Clamps, Artery Clamps receive FDA 510(k) clearance?

Vein Clamps, Artery Clamps received FDA 510(k) clearance on 2016-08-18, under 510(k) number K161315.

Who is the listed applicant for Vein Clamps, Artery Clamps?

The FDA 510(k) record lists Aros Surgical Instruments Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vein Clamps, Artery Clamps?

The FDA product code for Vein Clamps, Artery Clamps is DXC.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositifs connexes (Code : DXC)

K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc.K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards Lifesciences K252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc.K254060Life Saving TourniquetTW Medical K243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLC K253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)Medline Industries, LP

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.