Skip to content

Adelante Peel-Away Introducer Set AP11023P

by Oscor Inc.

Ref AP11023P

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

2 closed

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-00885672101251 Basic UDI-DI 00885672101251UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00885672101251 UDI-DI Date15 Nov 2017ListedStatusListed 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

2 recalls · FDA

    • Terminated Z-0055-2012 FDA Unclassified (pre-2012) initiated 1 Aug 2011

    The product may contain an incorrect size catheter and introducer.

    • Terminated Z-0130-2009 FDA Unclassified (pre-2012) initiated 3 Jul 2008

    Difficulty breaking the sheath hub and subsequently to peel the sheath off for Introducer Set, Adelante size 7F.

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  • Withdrawn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
Adelante Peel-Away Introducer EUDAMED
Adelante Peel-Away Introducer Set GUDID
Generic Name
Vascular catheter introduction set, nonimplantable
Model / Ref / Catalog
AP11023P
Primary DI / UDI-DI
00885672101251 EUDAMED
20885672101255 GUDID
Basic UDI-DI
B-00885672101251
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
Lumen/Inner Diameter — 3.7 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00885672101251
GUDID
20885672101255
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Vascular catheter introduction set, nonimplantable

Cleared under the same submission (K073100)

Show all (12)

Other devices from Oscor Inc.

See all devices from Oscor Inc. →

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