FDA 510(k)

XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set

K-Number: K242003 · 2024-12-16

Decision Date2024-12-16

Product CodeJXG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2024-12-16 under 510(k) number K242003. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set?

XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set is a medical device that received FDA 510(k) clearance on 2024-12-16. The listed applicant is Aesculap, Inc.. The 510(k) number is K242003.

When did XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set receive FDA 510(k) clearance?

XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set received FDA 510(k) clearance on 2024-12-16, under 510(k) number K242003.

Who is the listed applicant for XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set?

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

What is the FDA product code for XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set?

The FDA product code for XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set is JXG.

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Related Devices (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

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.