OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD— 510(k) K213593
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K213593 for OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD, Substantially Equivalent on 2022-01-14. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code OBJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Maple Grove, MN, US
Recent devices under product code OBJ
view allMore clearances from Boston Scientific Corporation
view allAdverse events under product code OBJ
product code OBJ- Death
- 38
- Injury
- 634
- Malfunction
- 3,453
- Total
- 4,125
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K213593
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K213593.
Data sourced from openFDA. This site is unofficial and independent of the FDA.