Seque Infusion Catheter (S-25, 30, 35, 40, 45, 50, 60)

by International Innovations, Inc.

510(k) K955534

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) K955534↗

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	NumberK955534	Date1 Aug 1996Cleared	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Withdrawn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: K955534
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, 23 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 Seque Infusion Catheter is a continuous flush catheter designed as an attachment to a catheter-transducer system. It facilitates continuous intravascular flushing at a slow infusion rate to help eliminate clotting, back-leakage, and waveform damping.

This device is classified as a Class 2 cardiovascular catheter under regulation number 870.1210. It is identified by the 510(k) number K955534 and is available in models S-25, 30, 35, 40, 45, 50, and 60.