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FDA 510(k)

Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)

K-Number: K261004 · 2026-06-23

ApplicantIntegra Lifesciences Production Corporation
Decision Date2026-06-23
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684) 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 2026-06-23 under 510(k) number K261004. 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 Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)?

Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684) is a medical device that received FDA 510(k) clearance on 2026-06-23. The listed applicant is Integra Lifesciences Production Corporation. The 510(k) number is K261004.

When did Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684) receive FDA 510(k) clearance?

Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684) received FDA 510(k) clearance on 2026-06-23, under 510(k) number K261004.

Who is the listed applicant for Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)?

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 Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)?

The FDA product code for Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684) is JXG.

Related Clinical Trials

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Other records listing Integra Lifesciences Production Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyK243552Codman 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 CatheterK233448Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter SetK223330Certas Plus Programmable Valves

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Related Devices (Code: JXG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251598IntellidropBrainspace, Inc.K250636Sophy Mini Monopressure Valve (SM1)SophysaK252514EVAC-MRIPhasor Health, LLCK243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production CorporationK243552Codman 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 CorporationK242974External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar CathetersSophysa

Official Source

View on FDA Database →

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

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