Cleared Traditional

Dorado? PTA Balloon Dilatation Catheter

K250219 · Bard Peripheral Vascular, Inc. · Cardiovascular
Jun 2025
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K250219 is an FDA 510(k) clearance for the Dorado? PTA Balloon Dilatation Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on June 17, 2025, 144 days after receiving the submission on January 24, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K250219 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 2025
Decision Date June 17, 2025
Days to Decision 144 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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