IsoFlow Infusion Catheter

by Vascular Designs, Inc.

510(k) K081147

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K081147↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK081147	Date29 May 2009Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K081147
FDA Product Code: KRA

Device Class: Class II
Regulation: 21 CFR Part 870.1210
Advisory Committee: Cardiovascular
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The IsoFlow Infusion Catheter is a catheter, continuous flush designed for the administration of fluids, medications, or contrast agents in cardiovascular procedures. Its multilumen design facilitates precise infusion while maintaining patency, reducing the risk of occlusion during use.

This device is intended for single-use in clinical settings such as interventional radiology or cardiology. Supplied sterile and non-reusable, it adheres to FDA 510(k) clearance under the Cardiovascular advisory committee classification. Multiple sizes and configurations are available, as referenced by the listed FEI numbers, and it is regulated under 21 CFR 870.1210.