FDA 510(k)

V-DAC Catheter

K-Number: K251097 · 2026-01-06

Decision Date2026-01-06

Product CodeQJP

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

V-DAC Catheter is a medical device manufactured by Vesalio, Inc.. It received FDA 510(k) clearance on 2026-01-06 under approval number K251097. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the V-DAC Catheter?

V-DAC Catheter is a medical device that received FDA 510(k) clearance on 2026-01-06. It is manufactured by Vesalio, Inc.. The 510(k) number is K251097.

When was V-DAC Catheter approved by the FDA?

V-DAC Catheter received FDA 510(k) clearance on 2026-01-06, under approval number K251097.

What company makes V-DAC Catheter?

V-DAC Catheter is manufactured by Vesalio, Inc..

What is the FDA product code for V-DAC Catheter?

The FDA product code for V-DAC Catheter is QJP.

Other Devices by Vesalio, Inc.

K253407NeVa PV Thrombectomy Device K251006NeVasc Aspiration System K251312Vesalio Peripheral System

Related Devices (Code: QJP)

K203043Route 92 Medical 070 Access SystemRoute 92 Medical, Inc. K201682RIST Radial Access CatheterRist Neurovascular, Inc. K201518Route 92 Medical 088 Access SystemRoute 92 Medical K201076Anchor Dual Lumen Guidewire CatheterAqure Medical, Inc. K200910BOSS Balloon Guide CatheterMarblehead Medical K200417RIST Radial Access CatheterRist Neurovascular, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.