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Arrow IPN921164

by Teleflex Incorporated

Ref CL-07900

Arrow IPN921164 (CL-07900) is a device classified as Class IIa in the EU and Class II in the US made by Teleflex Incorporated, registered in EUDAMED on 6 Jul 2026 (Basic UDI-DI B-10801902200959), cleared under FDA 510(k) K924607 on 22 Apr 1993 and listed in FDA GUDID since 9 Nov 2022 (UDI-DI 10801902200959), active as of 9 Nov 2026. 2 FDA recalls are linked to it.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None ongoing

3 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K924607

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10801902200959 Basic UDI-DI 10801902200959UDI-DIDate6 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10801902200959 UDI-DI Date9 Nov 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK924607 Date22 Apr 1993DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10801902200959 registered 6 Jul 2026 Active
  • FDA 510(k) K924607 decided 22 Apr 1993 Active
  • FDA GUDID UDI-DI 10801902200959 listed 9 Nov 2022 Listed

Recalls

3 recalls · FDA

    • Terminated Z-1064-2016 FDA Class II initiated 12 Jan 2016

    Arrow has issued a recall for these products due to potential packaging damage. The sterility of the products cannot be guaranteed. If non-sterile product is used there is a potential for infection to occur.

    • Terminated Z-1491-2009 FDA Unclassified (pre-2012) initiated 11 Feb 2009

    Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.

    • Terminated Z-0088-04 FDA Unclassified (pre-2012) initiated 22 Oct 2003 on shared 510(k) K924607

    package lid identifies the contents incorrectly

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

6 dated events

  1. Cleared FDA 510(k) K924607
  2. Recall initiated FDA recalls Z-0088-04
  3. Recall initiated FDA recalls Z-1491-2009
  4. Recall initiated FDA recalls Z-1064-2016
  5. Listed FDA GUDID 10801902200959
  6. Registered EUDAMED B-10801902200959

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Trade name
Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and Radiopaque Tip Marker Band EUDAMED
Arrow GUDID
Generic name
Vascular catheter introduction set, nonimplantable
Device name
Cath-Lab Sheath Intro Set:
Model / Ref / Catalog
CL-07900, IPN921164
Primary DI / UDI-DI
10801902200959
Basic UDI-DI
B-10801902200959
510(k) Number
FDA product code
DYB
EMDN code
C0502 Cardiovascular introducer sheaths, valved
GMDN term
Vascular catheter introduction set, nonimplantable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.1340
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
CL-07900
GUDID
IPN921164
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Vascular catheter introduction set, nonimplantable

Cleared under the same submission (K924607)

and 8 more cleared under K924607

Similar devices in this category

Other devices filed under CARDIOVASCULAR INTRODUCER SHEATHS, VALVED.

Other devices from Teleflex Incorporated

  • Arrow IPNB00820 Open recall

    Class II

  • Arrow IPNB00826 Open recall

    Class II

  • Arrow IPNB00822 Open recall

    Class II

  • Arrow IPNB00827 Open recall

    Class II

See all devices from Teleflex Incorporated →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)