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Prestige Coil System PRES0153CXPPL

by Balt USA LLC

Ref PRES0153CXPPL

Prestige Coil System PRES0153CXPPL is a device classified as Class IIb in the EU and Class II in the US made by Balt USA LLC, registered in EUDAMED on 13 Oct 2026 (Basic UDI-DI B-00840303708971), cleared under FDA 510(k) K220699 on 8 Apr 2022 (1 earlier submission) and listed in FDA GUDID since 22 Nov 2024 (UDI-DI 00840303708971), active as of 24 Oct 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

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K220699

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00840303708971 Basic UDI-DI 00840303708971UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840303708971 UDI-DI Date22 Nov 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK220699 Date8 Apr 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00840303708971 registered 13 Oct 2026 Active
  • FDA 510(k) K220699 decided 8 Apr 2022 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00840303708971 listed 22 Nov 2024 Listed

Recalls

7 recalls · 7 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1988-2025 FDA Class II initiated 8 May 2025 on shared 510(k) K200030
    • Ongoing Z-1989-2025 FDA Class II initiated 8 May 2025

    Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.

  • 2 recalls, same reason

    • Ongoing Z-1042-2024 FDA Class II initiated 3 Jan 2024
    • Ongoing Z-1041-2024 FDA Class II initiated 3 Jan 2024 on shared 510(k) K200030

    Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the delivery pusher. Due to the location of the delivery pusher within the delivery system, it is possible for the discoloration to mechanically break off from the delivery pusher, leaving the potential for the material to flow through the delivery system (i.e. microcatheter), and into the patient vasculature causing foreign emboli.

    • Ongoing Z-0103-2023 FDA Class II initiated 7 Sep 2022 on shared 510(k) K200030

    Product pouch label does not match up with carton label

    • Ongoing Z-1680-2022 FDA Class II initiated 26 Jul 2022 on shared 510(k) K200030

    Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.

    • Ongoing Z-0660-2022 FDA Class II initiated 4 Jan 2022 on shared 510(k) K200030

    Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. As a result of this labeling mix-up, there is the possibility of inadvertently selecting the incorrect coil size for the procedure potentially causing some harms like vessel damage, an inability to treat with said device and potential rupture of the aneurysm.

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

Timeline

11 dated events

  1. Recall initiated FDA recalls Z-0660-2022
  2. Cleared FDA 510(k) K220699
  3. Recall initiated FDA recalls Z-1680-2022
  4. Recall initiated FDA recalls Z-0103-2023
  5. Recall initiated FDA recalls Z-1042-2024
  6. Recall initiated FDA recalls Z-1041-2024
  7. Listed FDA GUDID 00840303708971
  8. Recall initiated FDA recalls Z-1988-2025
  9. Recall initiated FDA recalls Z-1989-2025
  10. Registered EUDAMED B-00840303708971

1 earlier event 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
Prestige Coil System
Generic name
Non-neurovascular embolization coil
Device name
Peripheral Embolization Device
Model / Ref / Catalog
PRES0153CXPPL
Primary DI / UDI-DI
00840303708971, 00818053027291
Basic UDI-DI
B-00840303708971
510(k) Number
FDA product code
KRD
EMDN code
Z12109001 Detachable coil equipment for brain aneurysms
GMDN term
Non-neurovascular embolization coil
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
870.3300
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Non-neurovascular embolization coil

Cleared under the same submission (K220699)

and 8 more cleared under K220699

Similar devices in this category

Other devices filed under NEUROLOGY AND NEUROSURGERY INSTRUMENTS.

Other devices from Balt USA LLC

See all devices from Balt USA LLC →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)