FDA 510(k)

Certas Plus Programmable Valves

K-Nummer: K223330 · 2023-02-01

AntragstellerIntegra Lifesciences Production Corporation

Entscheidungsdatum2023-02-01

ProduktcodeJXG

BeratungsausschussNE

EntscheidungSubstantially Equivalent

Produktübersicht

Certas Plus Programmable Valves is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Production Corporation. It received FDA 510(k) clearance on 2023-02-01 under 510(k) number K223330. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Certas Plus Programmable Valves?

Certas Plus Programmable Valves is a medical device that received FDA 510(k) clearance on 2023-02-01. The listed applicant is Integra Lifesciences Production Corporation. The 510(k) number is K223330.

When did Certas Plus Programmable Valves receive FDA 510(k) clearance?

Certas Plus Programmable Valves received FDA 510(k) clearance on 2023-02-01, under 510(k) number K223330.

Who is the listed applicant for Certas Plus Programmable Valves?

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

What is the FDA product code for Certas Plus Programmable Valves?

The FDA product code for Certas Plus Programmable Valves is JXG.

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

Weitere Einträge mit Integra Lifesciences Production Corporation als Antragsteller

K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology K243552Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter K233448Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set

Alle 9 Geräte anzeigen →

Verwandte Geräte (Code: JXG)

K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)Integra Lifesciences Production Corporation K251598IntellidropBrainspace, Inc.K250636Sophy Mini Monopressure Valve (SM1)Sophysa K252514EVAC-MRIPhasor Health, LLC K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production Corporation K243552Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)Integra Lifesciences Production Corporation

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.