FDA 510(k) clearance · back to tracker

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

Integra Lifesciences Production Corporation cleared K261004 on 2026-06-23, decision: substantially equivalent

K-number

K261004

Sponsor

Integra Lifesciences Production Corporation

Device

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

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-06-23

Product code

JXG

Advisory committee

Neurology

Medical specialty

Neurology

Regulation number

882.5550

Official FDA record

Open K261004on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.