Skip to content

Intri24 Introducer Sheath

by Inari Medical, Inc.

Ref 52-101

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

CE MDR 510(k)

Valid until

8 Nov 2028

CE MDR certificate

FDA recalls

None found

in data synced 22 Oct 2026

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

510(k) K252508↗

+2 more

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 Number1000332280 Date25 Sep 2026IssuedStatusActive expires 8 Nov 2028
United StatesFDA 510(k) 510(k) NumberK252508 Date17 Dec 2025IssuedStatusActive
United StatesGUDID listing GUDID Number00850291007260 UDI-DI Date20 Mar 2023ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000332280 Restricted

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    25 Sep 2026
    Expires
    8 Nov 2028
    Reason
    Other

Recalls

0 recalls · FDA

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

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  • Withdrawn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

Generic Name
Thrombectomy wire-net introduction set
Model / Ref / Catalog
52-101
Primary DI / UDI-DI
00850291007260
Basic UDI-DI
085029100752-101ZP
Direct Marketing DI
00850291007260
FDA Product Code
DYB
EMDN Code
C0502 Cardiovascular introducer sheaths, valved
GMDN Term
Thrombectomy wire-net introduction set
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1340
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000008693
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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 Intri24 Introducer Sheath is a medical device designed to provide a conduit for the insertion of endovascular devices into the vasculature. It functions to facilitate access while minimizing blood loss associated with such insertions.

This device is supplied sterile and is intended for single-use only. It is not reusable and is not an implantable device. The product is authorized under FDA 510K and MDR regulations, with model number 52-101.

Related devices

Category: Vascular catheter introduction set, nonimplantable

Other devices from Inari Medical, Inc.

See all devices from Inari Medical, Inc. →

Questions

AI-generated answers, 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.

  • What is the primary function of the Intri24 Introducer Sheath?

    The Intri24 is designed to serve as a conduit for the insertion of endovascular devices into the vasculature. It facilitates clinical access while specifically functioning to minimize blood loss during the insertion process.

  • Is the Intri24 Introducer Sheath reusable?

    No, this device is intended for single-use only. It is not designed to be reprocessed or reused, which ensures the sterility and integrity of the device for each individual patient procedure.

  • How is the device supplied to the clinician?

    The Intri24 Introducer Sheath is supplied in a sterile condition. This ensures that the device is ready for immediate use in a clinical environment without the need for additional sterilization steps by the end user.

  • Is the Intri24 an implantable device?

    No, the Intri24 Introducer Sheath is not an implantable device. It is categorized as a conduit for accessing the vasculature and is not intended to remain in the body as a permanent or semi-permanent implant.

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