Cleared Special

K240004 - CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ) (FDA 510(k) Clearance)

Also includes:
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

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K240004 · Circa Scientific, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2024
Decision
29d
Days
Class 2
Risk

K240004 is an FDA 510(k) clearance for the CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ). 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 January 31, 2024 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Circa Scientific, Inc. devices

Submission Details

510(k) Number K240004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2024
Decision Date January 31, 2024
Days to Decision 29 days
Submission Type Special
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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 700
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K240004.
Echo Large Bore Introducer Sheath
K260606 · Echo Medical, LLC · Apr 2026
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K254248 · Cardiocycle Medical(Suzhou) Co., Ltd. · Apr 2026
Edwards eSheath+ introducer set
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Aventus Introducer Sheath
K260091 · Inquis Medical · Apr 2026
Protaryx Transseptal Puncture Device (PTX2-001)
K260839 · Protaryx Medical, Inc. · Apr 2026
AuST Steerable Sheath
K260942 · CenterPoint Systems, LLC · Apr 2026