PacePro Wire
K-Number: K240864 · 2024-05-24
ApplicantOpsens, Inc.
Decision Date2024-05-24
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
PacePro Wire is a medical device manufactured by Opsens, Inc.. It received FDA 510(k) clearance on 2024-05-24 under approval number K240864. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PacePro Wire?
PacePro Wire is a medical device that received FDA 510(k) clearance on 2024-05-24. It is manufactured by Opsens, Inc.. The 510(k) number is K240864.
When was PacePro Wire approved by the FDA?
PacePro Wire received FDA 510(k) clearance on 2024-05-24, under approval number K240864.
What company makes PacePro Wire?
PacePro Wire is manufactured by Opsens, Inc..
What is the FDA product code for PacePro Wire?
The FDA product code for PacePro Wire is DQX.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.