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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 a medical device manufactured by Circa Scientific, Inc.. It received FDA 510(k) clearance on 2025-04-24 under approval 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. It is manufactured by Circa Scientific, Inc.. The 510(k) number is K243954.

When was PeriCross™ Epicardial Access Kit approved by the FDA?

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

What company makes PeriCross™ Epicardial Access Kit?

PeriCross™ Epicardial Access Kit is manufactured by Circa Scientific, Inc..

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

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

Other Devices by Circa Scientific, Inc.

K222311CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System K243193Cross Wise™ Multi-Use RF Adapter Cable K241414CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) K240004CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ); CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S); CardioCurve Steerable Sheath Medium Curl, 61cm (CC-1061M ); CardioCurve Steerable Sheath Large Curl, 61cm (CC-1061L); CardioCurve Steerable Sheath Small Curl, 71cm (CC-1071S ); CardioCurve Steerable Sheath Medium Curl, 71cm (CC-1071M ); CardioCurve Steer K251007CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)

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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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