Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of BALTLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list BALT USA with 19 510(k) clearances and 8 device recalls. The most recent is a 510(k) clearance dated Jul 13, 2026: SLIM Microcatheter.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 13, 2026 | SLIM MicrocatheterK260199 · QJP | 510(k) clearances |
| Apr 16, 2026 | Next Generation 088 CatheterK254223 · QJP | 510(k) clearances |
| Jan 27, 2026 | Optima Coil System (OptiOne Coil System)K254221 · HCG | 510(k) clearances |
| Oct 22, 2025 | Carrier XL Delivery CatheterK252569 · QJP | 510(k) clearances |
| Sep 26, 2025 | Optima Coil System (Optima Packing Coil System)K252700 · HCG | 510(k) clearances |
| Sep 25, 2025 | Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MClass I · Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter | Device recalls |
| Jun 3, 2025 | Raptor Aspiration Catheter; Balt Aspiration Tubing SetK243948 · NRY | 510(k) clearances |
| May 30, 2025 | Prestige Coil System (Prestige Packing Line Extension)K251383 · KRD | 510(k) clearances |
| May 8, 2025 | Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES14Class II · Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufa | Device recalls |
| May 8, 2025 | Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810Class II · Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufa | Device recalls |
| Dec 30, 2024 | Next Generation Access PlatformK242376 · QJP | 510(k) clearances |
| Jan 3, 2024 | Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiogrClass II · Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material w | Device recalls |
| Jan 3, 2024 | The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographicallyClass II · Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material w | Device recalls |
| Sep 7, 2022 | Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.Class II · Product pouch label does not match up with carton label | Device recalls |
| Jul 26, 2022 | Optima Coil System Model OPTI0520CSF10. For endovascular embolization.Class II · Products were released to customers prior to the approval and release of a test report authorizing the use of an existin | Device recalls |
| Jan 4, 2022 | The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless Class II · Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate m | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
