Cleared Traditional

Introducer Sheath Set

K251838 · Cardiocycle Medical(Suzhou) Co., Ltd. · Cardiovascular

Oct 2025

Decision

127d

Days

Class 2

Risk

About This 510(k) Submission

K251838 is an FDA 510(k) clearance for the Introducer Sheath Set, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Cardiocycle Medical(Suzhou) Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on October 21, 2025, 127 days after receiving the submission on June 16, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number	K251838 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 16, 2025
Decision Date	October 21, 2025
Days to Decision	127 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF