FDA applicant
Cardio Flow Inc.,
FDA records 5 decisions for Cardio Flow Inc., (Blaine, MN) from 2022 to 2025: 5 510(k) clearances. Most are in product codes MCW (Catheter, Peripheral, Atherectomy) and DQX (Wire, Guide, Catheter). Since 2016 its 510(k)s took a median of 99 days from receipt to decision, against 46 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 4 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Cardio Flow Inc.,’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Cardio Flow Inc.,’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report