Verge Microcatheter— 510(k) K261610

Name: FDA 510(k) clearance K261610
Creator: U.S. Food and Drug Administration
Published: 2026-06-11

Substantially Equivalent

Instylla, Inc.

FDA 510(k) clearance K261610 for Verge Microcatheter, Substantially Equivalent on 2026-06-11. Applicant: Instylla, Inc.. Device class: 2.

Summary

Instylla's Verge Microcatheter is filed under KRA, continuous flush catheters. The record gives no sizes or model numbers.

Class II, 21 CFR 870.1210. Cardiovascular is both the classification panel and the review panel, and it came in as a Special 510(k).

Instylla filed from Bedford, Massachusetts. Review took 28 calendar days (May 14 to June 11, 2026).

Clearance details

Applicant: Instylla, Inc.
Product code: Product code KRA
Device class: Class 2
Regulation: 21 CFR 870.1210
Advisory panel: Cardiovascular
Date received: 2026-05-14
Decision date: 2026-06-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KRA

product code KRA

Death: 234
Injury: 1,029
Malfunction: 3,012
Other: 2
Total: 4,277

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.