Cleared Traditional

K243954 - PeriCross Epicardial Access Kit

K243954 is an FDA 510(k) clearance for PeriCross Epicardial Access Kit, manufactured by Circa Scientific, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K243954 · Circa Scientific, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2025
Decision
122d
Days
Class 2
Risk

K243954 is an FDA 510(k) clearance for the PeriCross™ Epicardial Access Kit. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Circa Scientific, Inc. (Englewood, US). The FDA issued a Cleared decision on April 24, 2025 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Circa Scientific, Inc. devices

FDA 510(k) Submission Details - K243954

510(k) Number K243954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 125d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DYB Introducer, Catheter

All 432
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