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FDA 510(k)

PeriCross™ Epicardial Access Kit

K-Number: K243954 · 2025-04-24

ApplicantCirca Scientific, Inc.
Decision Date2025-04-24
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PeriCross™ Epicardial Access Kit is the device name listed in this FDA 510(k) record. The listed applicant is Circa Scientific, Inc.. It received FDA 510(k) clearance on 2025-04-24 under 510(k) number K243954. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PeriCross™ Epicardial Access Kit?

PeriCross™ Epicardial Access Kit is a medical device that received FDA 510(k) clearance on 2025-04-24. The listed applicant is Circa Scientific, Inc.. The 510(k) number is K243954.

When did PeriCross™ Epicardial Access Kit receive FDA 510(k) clearance?

PeriCross™ Epicardial Access Kit received FDA 510(k) clearance on 2025-04-24, under 510(k) number K243954.

Who is the listed applicant for PeriCross™ Epicardial Access Kit?

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

What is the FDA product code for PeriCross™ Epicardial Access Kit?

The FDA product code for PeriCross™ Epicardial Access Kit is DYB.

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Related Devices (Code: DYB)

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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