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Ballast 088 Long Sheath BALLAST100

by Balt USA LLC

Ref BALLAST100

Ballast 088 Long Sheath BALLAST100 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-00818053022906), cleared under FDA 510(k) K182918 on 21 Mar 2019 and listed in FDA GUDID since 15 Jul 2019 (UDI-DI 00818053022906), active as of 24 Oct 2026.

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 found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K182918

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-00818053022906 Basic UDI-DI 00818053022906UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00818053022906 UDI-DI Date15 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK182918 Date21 Mar 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00818053022906 registered 13 Oct 2026 Active
  • FDA 510(k) K182918 decided 21 Mar 2019 Active
  • FDA GUDID UDI-DI 00818053022906 listed 15 Jul 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K182918
  2. Listed FDA GUDID 00818053022906
  3. Registered EUDAMED B-00818053022906

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  • Withdrawn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
Ballast 088 Long Sheath
Generic name
Vascular guide-catheter, single-use
Device name
Percutaneous Catheter
Model / Ref / Catalog
BALLAST100
Primary DI / UDI-DI
00818053022906
Basic UDI-DI
B-00818053022906
510(k) Number
FDA product code
DQY
EMDN code
C0104020204 Peripheral angiography guide catheters
GMDN term
Vascular guide-catheter, single-use
Device class
Class III EUDAMED
Class II GUDID
Regulation number
870.1250
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

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: Vascular guide-catheter, single-use

Cleared under the same submission (K182918)

and 8 more cleared under K182918

Similar devices in this category

Other devices filed under PERIPHERAL ANGIOGRAPHY THERAPEUTIC DEVICES.

Other devices from Balt USA LLC

See all devices from Balt USA LLC →

Properties

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