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Equaflow Multivalve Infusion Catheter

by Cook Incorporated

510(k) K123235

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK123235 Date14 Feb 2013ClearedStatusActive

Official records

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  • Withdrawn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
DYB
Device class
Class II
Regulation
21 CFR Part 870.1340
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 6 Oct 2026

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

The Equaflow Multivalve Infusion Catheter is a single lumen catheter intended for delivering controlled infusions of intravascular therapeutic solutions. The catheter tip is designed with a tip valve, which allows occlusion of the catheter end hole without the use of a wire guide. The device features side valves spiraling along the specified infusion length.

The Equaflow Multivalve Infusion Catheter was cleared through the FDA 510(k) pathway on February 14, 2013, and is classified as a Class 2 device under product code DYB. It is manufactured by Cook Incorporated and supplied as a single-use device for intravascular infusion procedures.

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