FDA 510(k) Applications Submitted by Alice Ouyang

FDA 510(k) Number Submission Date Device Name Applicant
K240004 01/02/2024 CardioCurve 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 Steerab CIRCA Scientific, Inc.
K243954 12/23/2024 PeriCrossÖ Epicardial Access Kit CIRCA Scientific, Inc.


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