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Optima Coil System OPTI0103HSS10

by Balt USA LLC

Ref OPTI0103HSS10

Optima Coil System OPTI0103HSS10 is a device classified as Class III 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-00818053026591), cleared under FDA 510(k) K172390 on 18 Feb 2018 and listed in FDA GUDID since 27 Feb 2020 (UDI-DI 00818053026591), active as of 24 Oct 2026. 4 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

4 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K172390

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00818053026591 Basic UDI-DI 00818053026591UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00818053026591 UDI-DI Date27 Feb 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK172390 Date18 Feb 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00818053026591 registered 13 Oct 2026 Active
  • FDA 510(k) K172390 decided 18 Feb 2018 Active
  • FDA GUDID UDI-DI 00818053026591 listed 27 Feb 2020 Listed

Recalls

4 recalls · 4 ongoing · FDA

    • Ongoing Z-1988-2025 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.

    • Ongoing Z-1041-2024 FDA Class II initiated 3 Jan 2024

    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

    Product pouch label does not match up with carton label

    • Ongoing Z-1680-2022 FDA Class II initiated 26 Jul 2022

    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.

Timeline

7 dated events

  1. Cleared FDA 510(k) K172390
  2. Listed FDA GUDID 00818053026591
  3. Recall initiated FDA recalls Z-1680-2022
  4. Recall initiated FDA recalls Z-0103-2023
  5. Recall initiated FDA recalls Z-1041-2024
  6. Recall initiated FDA recalls Z-1988-2025
  7. Registered EUDAMED B-00818053026591

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
Optima Coil System
Generic name
Neurovascular embolization coil
Device name
Neurovascular embolization device
Model / Ref / Catalog
OPTI0103HSS10
Primary DI / UDI-DI
00818053026591
Basic UDI-DI
B-00818053026591
510(k) Number
FDA product code
HCG
EMDN code
Z12109001 Detachable coil equipment for brain aneurysms
GMDN term
Neurovascular embolization coil
Device class
Class III EUDAMED
Class II GUDID
Regulation number
882.5950
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 III
GUDID
Class II

Device class is stated on each registry's own scale: Class III 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: Neurovascular embolization coil

Cleared under the same submission (K172390)

and 8 more cleared under K172390

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)