NMI DIALYSIS CATHETER— 510(k) K131260

Name: FDA 510(k) clearance K131260
Creator: U.S. Food and Drug Administration
Published: 2014-02-14

Unknown

Navilyst Medical, Inc.

FDA 510(k) clearance K131260 for NMI DIALYSIS CATHETER, Unknown on 2014-02-14. Applicant: Navilyst Medical, Inc.. Device class: 2.

Clearance details

Applicant: Navilyst Medical, Inc.
Product code: Code MSD
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 2013-05-02
Decision date: 2014-02-14
Decision: Unknown
Clearance type: Traditional
Location: Marlborough, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MSD

product code MSD

Death: 67
Injury: 545
Malfunction: 3,661
Total: 4,273

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K131260

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131260.

Data sourced from openFDA. This site is unofficial and independent of the FDA.