Chrysalis Intelligence · Sponsors · Cardio Flow Inc.,

Cardio Flow Inc.,

Blaine, MN, US · 5 510(k) clearances

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Total clearances
5
2022-03-18 → 2025-04-25
Last 12 months
0
Product codes
2
Most recent
2025-04-25
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MCW Catheter, Peripheral, Atherectomy Class II Cardiovascular 4 2025-04-25
DQX Wire, Guide, Catheter Class II Cardiovascular 1 2022-03-18
Filings

All 510(k) clearances (5)

Date K-number Device Code Class Specialty
2025-04-25 K250723 FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) MCW Class II Cardiovascular
2024-11-05 K242947 FreedomFlow™ Orbital Circumferential Atherectomy System MCW Class II Cardiovascular
2024-02-15 K233483 FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) MCW Class II Cardiovascular
2023-09-27 K231538 FreedomFlow Orbital Circumferential Atherectomy System MCW Class II Cardiovascular
2022-03-18 K213834 Cardio Flow Peripheral Guide Wire DQX Class II Cardiovascular
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence