FDA 510(k)

Pompe ballon aortique intracardiaque AC3 Series Intra-Aortic Balloon Pump (IABP)

Numéro K : K192238 · 2019-11-12

Date de décision2019-11-12

Code produitDSP

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

AC3 Series Intra-Aortic Balloon Pump (IABP) is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, Teleflex. It received FDA 510(k) clearance on 2019-11-12 under 510(k) number K192238. The device is classified under product code DSP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the AC3 Series Intra-Aortic Balloon Pump (IABP)?

AC3 Series Intra-Aortic Balloon Pump (IABP) is a medical device that received FDA 510(k) clearance on 2019-11-12. The listed applicant is Arrow International, Teleflex. The 510(k) number is K192238.

When did AC3 Series Intra-Aortic Balloon Pump (IABP) receive FDA 510(k) clearance?

AC3 Series Intra-Aortic Balloon Pump (IABP) received FDA 510(k) clearance on 2019-11-12, under 510(k) number K192238.

Who is the listed applicant for AC3 Series Intra-Aortic Balloon Pump (IABP)?

The FDA 510(k) record lists Arrow International, Teleflex as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AC3 Series Intra-Aortic Balloon Pump (IABP)?

The FDA product code for AC3 Series Intra-Aortic Balloon Pump (IABP) is DSP.

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 : DSP)

K250542Pompe ballon aortique intracardiaque AC3 Range Intra-Aortic Balloon PumpArrow International, LLC K232343Série AC3 IABPArrow International, LLC K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc.K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitArrow International, Inc.K190101UltraFlex IABArrow International, Inc.K190117Fiberoptix IABArrow International, Inc.

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.