FDA 510(k)

Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter

Numéro K : K233445 · 2024-01-17

DemandeurIntegra Lifesciences Production Corporation

Date de décision2024-01-17

Code produitJXG

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter 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 2024-01-17 under 510(k) number K233445. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter?

Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter is a medical device that received FDA 510(k) clearance on 2024-01-17. The listed applicant is Integra Lifesciences Production Corporation. The 510(k) number is K233445.

When did Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter receive FDA 510(k) clearance?

Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter received FDA 510(k) clearance on 2024-01-17, under 510(k) number K233445.

Who is the listed applicant for Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter?

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 Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter?

The FDA product code for Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter is JXG.

Essais cliniques associés

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Autres dossiers indiquant Integra Lifesciences Production Corporation en tant que demandeur

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Dispositifs connexes (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

Source officielle

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