FDA applicant
Cardiovascular Systems, Inc.
FDA records 29 decisions for Cardiovascular Systems, Inc. (St.Paul, MN) from 2005 to 2022: 28 510(k) clearances and 1 original PMA approval. Most are in product codes MCW (Catheter, Peripheral, Atherectomy) and DQY (Catheter, Percutaneous). Since 2016 its 510(k)s took a median of 73 days from receipt to decision, against 97 for FDA’s reviews in the same codes and years. Its devices cite 55 predicates, 37 of them its own earlier devices. 13 recalls are linked to its devices, 3 Class I.
FDA’s records also spell it “Cardiovascular Systems Incorporated”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Cardiovascular Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
3in 2021
Class I Class II/III not classified
Planning a device like Cardiovascular Systems, 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) ReportOther applicant names beginning “Cardiovascular”
FDA records each applicant name separately; these may or may not be the same firm.