Decision Date2025-07-17
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
DualView Catheter is a medical device manufactured by Terumo Corporation. It received FDA 510(k) clearance on 2025-07-17 under approval number K250751. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DualView Catheter?
DualView Catheter is a medical device that received FDA 510(k) clearance on 2025-07-17. It is manufactured by Terumo Corporation. The 510(k) number is K250751.
When was DualView Catheter approved by the FDA?
DualView Catheter received FDA 510(k) clearance on 2025-07-17, under approval number K250751.
What company makes DualView Catheter?
DualView Catheter is manufactured by Terumo Corporation.
What is the FDA product code for DualView Catheter?
The FDA product code for DualView Catheter is DQO.
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Official Source
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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.