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CES MassTransit Infusion Catheter

by Cordis Neurovascular, Inc.

510(k) K974222

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

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

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK974222 Date10 Feb 1998ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
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, 26 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 CES MassTransit Infusion Catheter is a single-lumen catheter designed to access small, tortuous vasculature. It features a tapered shaft (3.0F proximal to 2.8F distal), a hydrophilic coating for navigation, and a PTFE-lined inner lumen to facilitate guidewire movement.

This device is used by clinicians to deliver diagnostic, therapeutic, or embolic agents to target sites within the peripheral vasculature. It is supplied as a sterile, single-use device and is not MRI compatible. The catheter is authorized under FDA 510(k) clearance with product code KRA and regulation number 870.1210.

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