VANES Delivery System (VDS)— 510(k) K260459

Name: FDA 510(k) clearance K260459
Creator: U.S. Food and Drug Administration
Published: 2026-04-06

Substantially Equivalent

Zoll Respicardia, Inc.

FDA 510(k) clearance K260459 for VANES Delivery System (VDS), Substantially Equivalent on 2026-04-06. Applicant: Zoll Respicardia, Inc.. Device class: 2.

Summary

Zoll Respicardia's VANES Delivery System (VDS) is filed under product code DYB (Introducer, Catheter). The record doesn't describe the system beyond its name and that code name.

Class II, 21 CFR 870.1340. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).

Zoll Respicardia filed from Minnetonka, Minnesota. The record shows 54 calendar days from receipt to decision (February 11 to April 6, 2026).

Clearance details

Applicant: Zoll Respicardia, Inc.
Product code: Product code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 2026-02-11
Decision date: 2026-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, 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.