DeviceClearance

NAMIC Dilator and Sheath— 510(k) K253526

Substantially Equivalent

Medline Industries, LP

FDA 510(k) clearance K253526 for NAMIC Dilator and Sheath, Substantially Equivalent on 2026-07-29. Applicant: Medline Industries, LP. Device class: 2.

Summary

Medline Industries' NAMIC Dilator and Sheath is filed under DYB, catheter introducers. The record doesn't give sizes or lengths.

Class II, 21 CFR 870.1340. Cardiovascular is both the classification panel and the review panel, and it was a Traditional 510(k).

Medline filed from Northfiled (as the record spells it), Illinois. The decision came 258 calendar days after FDA received it (November 13, 2025 to July 29, 2026).

Clearance details

Applicant
Medline Industries, LP
Product code
Product code DYB
Device class
Class 2
Regulation
21 CFR 870.1340
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Northfiled, IL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DYB

product code DYB
Death
808
Injury
5,922
Malfunction
16,516
Other
5
Total
23,251

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

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