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

K240004 · Circa Scientific, Inc. · Cardiovascular device

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 ). This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).

Submitted by Circa Scientific, Inc. (Englewood, US). The FDA issued a Cleared decision on January 31, 2024, 29 days after receiving the submission on January 2, 2024.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.

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