510(k) K242376 ยท QJP Catheter, Percutaneous, Neurovasculature
Next Generation Access Platform
| Applicant | Balt USA, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Dec 30, 2024 |
| Received | Aug 9, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242376
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2025 | BALT USA, LLC Brand Name: MEGA Ballast Distal Access Platform
Product Name: Mega Ballast
Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110
Software Version: N/A
Product Description: The Meg Open, Classified |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.