K-number	K251838
Device name	Introducer Sheath Set
Applicant	Cardiocycle Medical(Suzhou) Co., Ltd.
Product code	DYB
Device class	Class II
Decision date	Oct 21, 2025
Decision	Substantially Equivalent
Regulation	870.1340

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Introducer Sheath Set is a sterile, disposable device consisting of a sheath and dilator used in vascular procedures. It is inserted into blood vessels to provide a conduit for endovascular device insertion while minimizing blood loss during the procedure.

Technological characteristics

The device features a hydrophilic-coated sheath tube with a hemostatic valve, paired with a dilator assembly. The main differences from the predicate (GORE® DrySeal Flex) are that this device does not include a syringe and has fewer model specifications. Both are sterilized with ethylene oxide.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

The Introducer Sheath Set has identical intended use and indications for use as the predicate device. Comprehensive performance testing including dimensional analysis, mechanical testing, simulated-use vessel models, sterility, biocompatibility, and packaging validation all supported substantial equivalence to the predicate.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Introducer Sheath Set

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