Boston Scientific Corp · Class II · Cleared Oct 18, 2024
| K-number | K243245 |
| Device name | IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) |
| Applicant | Boston Scientific Corp |
| Product code | GEH |
| Device class | Class II |
| Decision date | Oct 18, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 878.4350 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov