Multiflex Steerable Sheath 17.5F— 510(k) K260626

Name: FDA 510(k) clearance K260626
Creator: U.S. Food and Drug Administration
Published: 2026-03-26

Substantially Equivalent

Vizaramed, Inc.

FDA 510(k) clearance K260626 for Multiflex Steerable Sheath 17.5F, Substantially Equivalent on 2026-03-26. Applicant: Vizaramed, Inc.. Device class: 2.

Summary

Vizaramed's Multiflex Steerable Sheath 17.5F is filed under DYB, catheter introducers. The record lists only the 17.5F size given in the name.

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

Vizaramed filed from San Jose, California. The decision came 28 calendar days after FDA received it (February 26 to March 26, 2026).

Clearance details

Applicant: Vizaramed, Inc.
Product code: Product code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 2026-02-26
Decision date: 2026-03-26
Decision: Substantially Equivalent
Clearance type: Special
Location: San Jose, CA, US

Download summary PDF View 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, 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 →

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