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NA PIK Dilator small

by Maquet Cardiopulmonary AG

Ref 701054606Model PIK dilator S

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04037691746500 Basic UDI-DI 04037691746500UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04037691746500 UDI-DI Date3 Jun 2016ListedStatusListed 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

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-3144-2026 FDA Class II initiated 31 Jul 2026
    • Ongoing Z-3145-2026 FDA Class II initiated 31 Jul 2026
    • Ongoing Z-3146-2026 FDA Class II initiated 31 Jul 2026

    The packaging may not consistently maintain sterile barrier integrity.

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  • Withdrawn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
PIK dilator small 8/10Fr
Generic Name
Vascular dilator, single-use
Device Name
PIK dilator set small 8/10 Fr
Model / Ref / Catalog
PIK dilator S EUDAMED
701054606 EUDAMED
PIK Dilator small GUDID
70105.4606 GUDID
Primary DI / UDI-DI
04037691746500
Basic UDI-DI
B-04037691746500
510(k) Number
FDA Product Code
DWF
EMDN Code
C0699 Cardiovascular surgery instruments, single-use - other
GMDN Term
Vascular dilator, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.4210
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
PIK dilator S
701054606
GUDID
PIK Dilator small
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Vascular dilator, single-use

Cleared under the same submission (K131666)

Other devices from Maquet Cardiopulmonary AG

See all devices from Maquet Cardiopulmonary AG →

Properties

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

Other properties (16)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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