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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Opsens, Inc.. It received FDA 510(k) clearance on 2024-05-24 under 510(k) 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. The listed applicant is Opsens, Inc.. The 510(k) number is K240864.

When did PacePro Wire receive FDA 510(k) clearance?

PacePro Wire received FDA 510(k) clearance on 2024-05-24, under 510(k) number K240864.

Who is the listed applicant for PacePro Wire?

The FDA 510(k) record lists Opsens, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PacePro Wire?

The FDA product code for PacePro Wire is DQX.

Other records listing Opsens, Inc. as applicant

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Related Devices (Code: DQX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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