Cardio Flow

Timeline

1. Apr 25, 2025 FDA FDA 510(k) clearance: FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) — K250723, Apr 25, 2025. Applicant at approval: Cardio Flow Inc.,. source ↗
2. Nov 5, 2024 FDA FDA 510(k) clearance: FreedomFlow™ Orbital Circumferential Atherectomy System — K242947, Nov 5, 2024. Applicant at approval: Cardio Flow Inc.,. source ↗

FDA records (last 2 years)

• Apr 25, 2025 FDA 510(k) clearance: FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) — K250723, Apr 25, 2025. Applicant at approval: Cardio Flow Inc.,. source ↗
• Nov 5, 2024 FDA 510(k) clearance: FreedomFlow™ Orbital Circumferential Atherectomy System — K242947, Nov 5, 2024. Applicant at approval: Cardio Flow Inc.,. source ↗