FDA 510(k)

Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set

N.º K: K233448 · 2023-12-19

SolicitanteIntegra Lifesciences Production Corporation

Fecha de decisión2023-12-19

Código de productoJXG

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set 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 2023-12-19 under 510(k) number K233448. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set?

Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set is a medical device that received FDA 510(k) clearance on 2023-12-19. The listed applicant is Integra Lifesciences Production Corporation. The 510(k) number is K233448.

When did Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set receive FDA 510(k) clearance?

Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set received FDA 510(k) clearance on 2023-12-19, under 510(k) number K233448.

Who is the listed applicant for Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set?

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 Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set?

The FDA product code for Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set is JXG.

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Otros registros que enlistan a Integra Lifesciences Production Corporation como solicitante

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 K223330Certas Plus Programmable Valves

Ver todos los 9 dispositivos →

Dispositivos relacionados (Código: 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

Fuente oficial

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