FDA.report

510(k) K251838

Device
Introducer Sheath Set
Applicant
Cardiocycle Medical(Suzhou) Co., Ltd.
510(k) number
K251838
Product code
DYB
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-21
Date received
2025-06-16
Regulation
870.1340
Classification name
Introducer, Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Ling Li
Address
Unit 401&501, Bldg. C15, Stage 5, Biobay #21 Chaoqian Rd., Suzhou Industrial Park Suzhou, Jiangsu CN 215000 215000

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code DYB

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K254236Peel-Away Introducer SheathVascuTech Medical, LLC2026-02-09
K253652Genie MAX Large Bore Introducer SheathCultiv8 1, LLC2026-01-22
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K253741V•Stick™ Vascular Access SetArgon Medical Devices, Inc.2025-12-15
K252309PerQseal IntroducersVivasure Medical Limited2025-10-23
K25276614Fr Low Profile Introducer KitAbiomed, Inc.2025-10-08