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Mahurkar 8888135241

by Mozarc Medical US LLC

Ref 8888135241Model Mahurkar Acute Dual Lumen Catheter

Mahurkar 8888135241 is a device classified as Class IIa in the EU and Class II in the US made by Mozarc Medical US LLC, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-20884521006536), cleared under FDA 510(k) K192302 on 17 Jan 2020 (1 earlier submission) and listed in FDA GUDID since 31 Aug 2015 (UDI-DI 20884521006536), active as of 7 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

7 ongoing

Recall on shared 510(k) K192302, K030209; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K192302

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-20884521006536 Basic UDI-DI 20884521006536UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesFDA 510(k)SEKD GUDID from GUDID Traditional NumberK192302 Date17 Jan 2020DecidedStatusActive
United StatesGUDID listing GUDID Number20884521006536 UDI-DI Date31 Aug 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-20884521006536 registered 30 Oct 2026 Active
  • FDA 510(k) K192302 decided 17 Jan 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 20884521006536 listed 31 Aug 2015 Listed

Recalls

10 recalls · 7 ongoing · FDA

  • 6 recalls, same reason

    • Ongoing Z-0421-2026 FDA Class II initiated 17 Oct 2025 on shared 510(k) K192302
    • Ongoing Z-0426-2026 FDA Class II initiated 17 Oct 2025 on shared 510(k) K192302
    • Ongoing Z-0422-2026 FDA Class II initiated 17 Oct 2025 on shared 510(k) K192302
    • Ongoing Z-0423-2026 FDA Class II initiated 17 Oct 2025 on shared 510(k) K192302
    • Ongoing Z-0425-2026 FDA Class II initiated 17 Oct 2025 on shared 510(k) K192302
    • Ongoing Z-0424-2026 FDA Class II initiated 17 Oct 2025 on shared 510(k) K192302

    A potential issue with the seal integrity of header bag packaging.

    • Ongoing Z-0877-2023 FDA Class I initiated 7 Dec 2022 on shared 510(k) K030209

    There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

    • Terminated Z-1955-2019 FDA Class II initiated 29 Apr 2019 on shared 510(k) K030209

    The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen.

    • Terminated Z-0233-04 FDA Unclassified (pre-2012) initiated 2 Dec 2003

    Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5Fr x 16.0 cm

    • Terminated Z-0234-04 FDA Unclassified (pre-2012) initiated 2 Dec 2003

    Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5 Fr x 16.0 cm

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

Timeline

14 dated events

  1. Recall initiated FDA recalls Z-1955-2019
  2. Cleared FDA 510(k) K192302
  3. Recall initiated FDA recalls Z-0877-2023
  4. Recall initiated FDA recalls Z-0421-2026
  5. Recall initiated FDA recalls Z-0426-2026
  6. Recall initiated FDA recalls Z-0422-2026
  7. Recall initiated FDA recalls Z-0423-2026
  8. Recall initiated FDA recalls Z-0425-2026
  9. Recall initiated FDA recalls Z-0424-2026
  10. Registered EUDAMED B-20884521006536

4 earlier events are in the sections above.

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
MAHURKAR™Acute Dual Lumen Catheter Kit High Flow Straight Extensions 13.5 Fr/Ch (4.5 mm) x 24 cm EUDAMED
Mahurkar GUDID
Generic name
Double-lumen haemodialysis catheter, nonimplantable
Model / reference
8888135241, Mahurkar Acute Dual Lumen Catheter
Primary DI / UDI-DI
20884521006536 EUDAMED
10884521006539 GUDID
Basic UDI-DI
B-20884521006536
510(k) Number
FDA product code
MPB
EMDN code
F900201 Temporary hemodialysis catheters and kits
GMDN term
Double-lumen haemodialysis catheter, nonimplantable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.5540
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 24 Centimeter
Catheter Gauge — 13.5 French

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
20884521006536
GUDID
10884521006539
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 20884521006536; FDA GUDID lists 10884521006539), so their flags are not compared. 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: Double-lumen haemodialysis catheter, nonimplantable

Cleared under the same submission (K030209)

and 8 more cleared under K030209

Cleared under the same submission (K192302)

and 8 more cleared under K192302

Similar devices in this category

Other devices filed under TEMPORARY HEMODIALYSIS CATHETERS AND KITS.

Other devices from Mozarc Medical US LLC

See all devices from Mozarc Medical US LLC →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)