FDA applicant
Vascular Solutions, Inc.
FDA records 116 decisions for Vascular Solutions, Inc. (Minneapolis, MN) from 2000 to 2024: 115 510(k) clearances and 1 original PMA approval. Most are in product codes DQY (Catheter, Percutaneous) and QSX (Hemostatic Wound Dressing With Thrombin Or…). Since 2016 its 510(k)s took a median of 86 days from receipt to decision, against 113 for FDA’s reviews in the same codes and years. Its devices cite 183 predicates, 103 of them its own earlier devices. 25 recalls are linked to its devices, 9 Class I.
FDA’s records also spell it “Vascular Solutions, LLC”, “Vascular Solutions”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Vascular Solutions, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
1in 2023
Class I Class II/III not classified
Planning a device like Vascular Solutions, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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