← Product Code [OBJ](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ) · K260816

# 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) (K260816)

_Boston Scientific · OBJ · Apr 8, 2026 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ/K260816

## Device Facts

- **Applicant:** Boston Scientific
- **Product Code:** [OBJ](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ.md)
- **Decision Date:** Apr 8, 2026
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 870.1200
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ/K260816](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ/K260816)

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