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Introducer Kit for Impella® 0052-3021

by Oscor Inc.

Ref 0052-3021

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

3 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00885672009786 Basic UDI-DI 00885672009786UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00885672009786 UDI-DI Date24 Sep 2019ListedStatusListed GUDID: in commercial distribution

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

4 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-2678-2026 FDA Class I initiated 10 Jun 2026
    • Ongoing Z-2679-2026 FDA Class I initiated 10 Jun 2026
    • Ongoing Z-2680-2026 FDA Class I initiated 10 Jun 2026

    Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.

    • Terminated Z-1467-2021 FDA Class II initiated 22 Feb 2021

    AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of the kit identified below is affected by this recall action. The Product Description, Product Number, Ref./Catalog Number and Batch/Lot number is provided below. No other products are affected by this recall.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Abiomed Introducer Kit for Impella EUDAMED
Introducer Kit for Impella® GUDID
Generic Name
Vascular catheter introduction set, nonimplantable
Model / Ref / Catalog
0052-3021
Primary DI / UDI-DI
00885672009786
Basic UDI-DI
B-00885672009786
510(k) Number
FDA Product Code
DYB
EMDN Code
C0503 Cardiovascular introducer sheaths, peel-away
GMDN Term
Vascular catheter introduction set, nonimplantable
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
870.1340
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Length — 30 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Vascular catheter introduction set, nonimplantable

Cleared under the same submission (K122084)

Show all (12)

Other devices from Oscor Inc.

See all devices from Oscor Inc. →

Properties

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

Other properties (17)

  • 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
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No