OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)
FDA 510(k) clearance K260816 · decided 2026-04-08
Clearance details
- K-number
- K260816
- Device name
- OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)
- Applicant
- Boston Scientific
- Decision
- Substantially Equivalent
- Date received
- 2026-03-13
- Decision date
- 2026-04-08
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- OBJ
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|
| ICD INOGEN VR DF4 (D010); ICD INOGEN VR DF1/IS1 (D011); ICD INOGEN DR DF4/IS1 (D012); ICD INOGEN DR DF1/IS1 (D013); (P960040/S516) | Boston Scientific | 2026-07-23 |
| ESSENTIO MRI SR SL (L110); ESSENTIO MRI DR SL (L111); ESSENTIO MRI DR EL (L131); PROPONENT MRI SR SL (L210); PROPONE (P150012/S189) | Boston Scientific | 2026-07-23 |
| LATITUDE NXT Remote Patient Management System; LATITUDE NXT System Server Software Model 6460 (P910077/S198) | Boston Scientific | 2026-07-01 |
| INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S182) | Boston Scientific | 2026-07-01 |
| TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA (P960040/S513) | Boston Scientific | 2026-07-01 |
| LD INGEVITY PLUS AF (P150012/S188) | Boston Scientific | 2026-06-09 |
| RELIANCE S Passive Single Coil, RELIANCE S Active Fix Single Coil, RELIANCE Passive Dual Coil, RELIANCE Active Fix Dual (P910073/S192) | Boston Scientific | 2026-06-09 |
| ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S185) | Boston Scientific | 2026-06-03 |