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Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design; Flexor Up and Over Balkin Contralateral Introducer; Flexor Check-Flo Introducer, Raabe Modification; Flexor Check-Flo Performer Introducer

by Cook Incorporated

510(k) K142829Ref KCFW-9.0-38-55-RB-RAABE

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K142829↗

FDA record

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0827002CINC050-031_C1Y7 Basic UDI-DI 00827002363939UDI-DIDate16 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00827002363939 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK142829 Date28 Jul 2015ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

26 recalls · 1 ongoing · FDA

    • Ongoing Z-0993-2026 FDA Class II initiated 26 Nov 2025

    Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.

  • 2 recalls, same reason

    • Terminated Z-0388-2022 FDA Class II initiated 12 Nov 2021
    • Terminated Z-0387-2022 FDA Class II initiated 12 Nov 2021

    Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa

  • 2 recalls, same reason

    • Terminated Z-0186-2022 FDA Class II initiated 28 Sep 2021
    • Terminated Z-0185-2022 FDA Class II initiated 28 Sep 2021

    Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in the patient and viewed under fluoroscopy, leading to increased procedural time.

  • 21 recalls, same reason

    • Terminated Z-0600-2021 FDA Class I initiated 24 Nov 2020
    • Terminated Z-0604-2021 FDA Class I initiated 24 Nov 2020
    • Terminated Z-0611-2021 FDA Class I initiated 24 Nov 2020
    • Terminated Z-0591-2021 FDA Class I initiated 24 Nov 2020
    • Terminated Z-0610-2021 FDA Class I initiated 24 Nov 2020
    • Terminated Z-0609-2021 FDA Class I initiated 24 Nov 2020
    • Terminated Z-0603-2021 FDA Class I initiated 24 Nov 2020
    • Terminated Z-0596-2021 FDA Class I initiated 24 Nov 2020
    • Terminated Z-0607-2021 FDA Class I initiated 24 Nov 2020
    • Terminated Z-0593-2021 FDA Class I initiated 24 Nov 2020
    • Terminated Z-0598-2021 FDA Class I initiated 24 Nov 2020
    • Terminated Z-0601-2021 FDA Class I initiated 24 Nov 2020
    • Terminated Z-0592-2021 FDA Class I initiated 24 Nov 2020
    • Terminated Z-0605-2021 FDA Class I initiated 24 Nov 2020
    • Terminated Z-0606-2021 FDA Class I initiated 24 Nov 2020
    • Terminated Z-0608-2021 FDA Class I initiated 24 Nov 2020
    • Terminated Z-0602-2021 FDA Class I initiated 24 Nov 2020
    • Terminated Z-0595-2021 FDA Class I initiated 24 Nov 2020
    • Terminated Z-0599-2021 FDA Class I initiated 24 Nov 2020
    • Terminated Z-0597-2021 FDA Class I initiated 24 Nov 2020
    • Terminated Z-0594-2021 FDA Class I initiated 24 Nov 2020

    There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.

Coverage

2 jurisdictions

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

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Flexor® Check-Flo® EUDAMED
Flexor GUDID
Generic Name
Vascular catheter introduction set, nonimplantable
Device Name
Flexor® Check-Flo® Introducer [Set, Raabe Modification, Balkin Up & Over® Contralateral Design]
Model / Ref / Catalog
KCFW-9.0-38-55-RB-RAABE, G36393
Primary DI / UDI-DI
00827002363939
Basic UDI-DI
0827002CINC050-031_C1Y7
510(k) Number
FDA Product Code
DYB
EMDN Code
C0502 Cardiovascular introducer sheaths, valved
GMDN Term
Vascular catheter introduction set, nonimplantable
Models / Variants
Device Class
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 870.1340
EU market of registration
Germany
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
Model / ReferenceEUDAMED
KCFW-9.0-38-55-RB-RAABE
510(k)
—
GUDID
G36393
Device ClassEUDAMED
Class IIa
510(k)
Class II
GUDID
Class II

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.

This device is a vascular introducer designed for the insertion of therapeutic or diagnostic devices into peripheral vasculature, excluding coronary and neuro vasculature. The introducers feature modifications such as the Ansel, Balkin Up and Over Contralateral, and Raabe designs, as well as variations including a high-flex dilator with hydrophilic coating. They are intended for use in interventional procedures requiring controlled access to blood vessels.

The introducers are supplied sterile and intended for single-use. They are categorized under product code DYB and have received FDA 510(k) clearance through a traditional review process by the Cardiovascular (CV) Advisory Committee. Sizes and specific modifications are detailed in the product specifications, and they are manufactured by Cook Incorporated. No MRI safety information is provided in the available data.

Other devices from Cook Incorporated

See all devices from Cook Incorporated →

Questions

AI-generated answers, 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.

  • What types of vascular procedures are these introducers designed for, and which blood vessels are excluded from use?

    These introducers are specifically designed for peripheral vasculature procedures, allowing controlled access for therapeutic or diagnostic devices. They are not intended for coronary or neurovascular applications, meaning they should not be used in heart or brain-related blood vessels.

  • Are these introducers reusable or single-use, and how are they supplied?

    These introducers are sterile and intended for single-use only, ensuring patient safety and reducing infection risks. They are supplied pre-sterilized, ready for immediate use in clinical settings.

  • What special features do some of these introducers include, and how might they benefit a clinician?

    Several models feature modifications like the Ansel, Balkin Up and Over Contralateral, and Raabe designs, which enhance procedural flexibility. Additionally, some include a high-flex dilator with a hydrophilic coating, reducing friction and improving ease of insertion during interventional procedures.

  • How do I determine the correct size or model for my patient’s needs?

    The available sizes and specific modifications (e.g., Ansel, Balkin, Raabe) are detailed in the product specifications, which should be consulted to match the introducer to the patient’s vascular anatomy and procedural requirements.

  • What regulatory pathway was followed for FDA clearance, and which advisory committee reviewed this device?

    These introducers received FDA 510(k) clearance through a traditional review process, with the Cardiovascular (CV) Advisory Committee providing expert input. The decision was based on substantial equivalence to a predicate device, ensuring compliance with safety and performance standards.

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No