510(k) K220699 ยท KRD Device, Vascular, For Promoting Embolization
Prestige Coil System
| Applicant | Bait USA, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Apr 8, 2022 |
| Received | Mar 10, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K220699
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2025 | BALT USA, LLC Prestige Coil System REFs/UDI-DI codes:
PRES0153CXPPLT 00810068567311
PRES1045CPKPLT 00810068567663
PRES1245CPKPLT 00810068567694
PRES1445CPKPLT 00810068567724
PRES0103CXPPLT 00810068567304
PRES2512CX Open, Classified |
KRD | None listed |
| Feb 8, 2024 | BALT USA, LLC The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral va Open, Classified |
KRD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.