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Dilator Sets

by Cook Incorporated

510(k) K183036

Active European Union and United States

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

3 ongoing

Recall on shared 510(k) K183036; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K183036↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK183036 Date20 Dec 2018ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-1531-2024 FDA Class II initiated 1 Mar 2024 on shared 510(k) K183036
    • Ongoing Z-1532-2024 FDA Class II initiated 1 Mar 2024 on shared 510(k) K183036
    • Ongoing Z-1530-2024 FDA Class II initiated 1 Mar 2024 on shared 510(k) K183036

    Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
DRE
Device class
Class II
Regulation
21 CFR Part 870.1310
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Dilator Sets are Vessel Dilators for Percutaneous Catheterization, designed to facilitate the dilation of vascular access sites. These devices are used in conjunction with catheters to enlarge the lumen of blood vessels, ensuring proper placement and function of intravascular lines, particularly in cardiovascular procedures.

These sets are intended for single-use in clinical environments and are supplied sterile. They are classified as Class II medical devices under FDA regulations (510(k) clearance) and comply with the Medical Device Directive (MDD). The sets are available in multiple sizes and configurations, as indicated by the associated FEI numbers, and are intended for use in percutaneous catheterization procedures. No MRI safety information is specified.

Other devices from Cook Incorporated

See all devices from Cook Incorporated →

Questions

AI-generated answers, 18 Sep 2026

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

  • What clinical procedures are these Dilator Sets primarily used for?

    These Dilator Sets are designed specifically for percutaneous catheterization procedures, where they help dilate vascular access sites to ensure proper placement and function of intravascular lines. They are commonly used in cardiovascular procedures to enlarge the lumen of blood vessels, facilitating catheter insertion and maintaining patency.

  • Are these Dilator Sets reusable or intended for single-use only?

    The Dilator Sets are explicitly intended for single-use only in clinical environments. This design ensures sterility and safety, as reuse could compromise integrity and introduce infection risks.

  • How are these Dilator Sets supplied, and are they sterile?

    The Dilator Sets are supplied sterile and ready for immediate clinical use. They are packaged to maintain sterility until opened, adhering to medical device standards for single-use procedures.

  • What regulatory pathways have these Dilator Sets undergone, and which committees were involved?

    These Dilator Sets have received FDA 510(k) clearance under the Traditional pathway, classified as Class II devices. The submission was reviewed by the Cardiovascular (CV) Advisory Committee, and the decision was based on a Substantially Equivalent (SESE) determination. They also comply with the Medical Device Directive (MDD) in the EU.

  • How many different sizes or configurations are available for these Dilator Sets?

    The Dilator Sets come in multiple sizes and configurations, each identified by unique FEI numbers (e.g., 2527072, 3009211636, etc.). Over 60 distinct FEI numbers are listed, indicating a wide range of options to accommodate different vascular access sites and procedural needs.