Cleared Traditional

PeriCross? Epicardial Access Kit

K243954 · Circa Scientific, Inc. · Cardiovascular
Apr 2025
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K243954 is an FDA 510(k) clearance for the PeriCross? Epicardial Access Kit, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Circa Scientific, Inc. (Englewood, US). The FDA issued a Cleared decision on April 24, 2025, 122 days after receiving the submission on December 23, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K243954 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2024
Decision Date April 24, 2025
Days to Decision 122 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340

More from Circa Scientific, Inc.

View all
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)
K251007 · DXF · May 2025
Cross Wise? Multi-Use RF Adapter Cable
K243193 · DXF · Nov 2024
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)
K241414 · DXF · Sep 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 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
K240004 · DYB · Jan 2024
CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System
K222311 · FLL · May 2023