FDA 510(k)

AC3 Series Intra-Aortic Balloon Pump (IABP)

K-Nummer: K192238 · 2019-11-12

AntragstellerArrow International, Teleflex

Entscheidungsdatum2019-11-12

ProduktcodeDSP

BeratungsausschussCV

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

Zugehörige klinische Studien

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

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

Verwandte Geräte (Code: DSP)

K250542AC3® Range® Intra-Aortic Balloon PumpArrow International, LLC K232343AC3® Series IABPArrow International, LLC K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc.K200634Arrow FiberOptix Intra-Aortische Ballonkatheter套装Arrow International, Inc.K190101UltraFlex IABArrow International, Inc.K190117Fiberoptix IABArrow International, Inc.

Offizielle Quelle

In der FDA-Datenbank anzeigen →

Daten aus der FDA Open API. Für die aktuellsten und verbindlichen Informationen konsultieren Sie bitte stets den offiziellen Datensatz.