Introducer Sheath Kits

FDA 510(k) K242248 · Beijing Demax Medical Technology Co.,Ltd

Substantially Equivalent

510(k) numberK242248

Submission

Device name
Introducer Sheath Kits
Applicant
Beijing Demax Medical Technology Co.,Ltd
Beijing, CN
Received
July 31, 2024
Decision date
August 22, 2024
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DYB – Introducer, Catheter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1340
Specialty
Cardiovascular

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K261242SimplGuideDYB · Traditional Pendracare06/25/2026SE
K261950Health Line Tearaway IntroducerDYB · Traditional Health Line International Corporation06/22/2026SE
K261492FieldFlex Steerable SheathDYB · Special CenterPoint Systems, LLC06/05/2026SE
K260606Echo Large Bore Introducer SheathDYB · Traditional Echo Medical, LLC04/29/2026SE
K254248Introducer Sheath SetDYB · Traditional Cardiocycle Medical(Suzhou) Co., Ltd.04/23/2026SE
K254279Edwards eSheath+ introducer setDYB · Traditional Edwards Lifesciences04/17/2026SE
K260091Aventus Introducer SheathDYB · Traditional Inquis Medical04/13/2026SE
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Questions and answers

When was Introducer Sheath Kits cleared by the FDA?

Introducer Sheath Kits (K242248) received a 510(k) decision of Substantially Equivalent on August 22, 2024, 22 days after the submission was received.

What is the product code of K242248?

The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.