Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090)

Q: What is the product code of K242756?

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

FDA 510(k) K242756 · Pulnovo Medical (Wuxi) Co., Ltd.

Substantially Equivalent

510(k) numberK242756

Submission

Device name: Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090)
Applicant: Pulnovo Medical (Wuxi) Co., Ltd.
Wuxi, CN
Received: September 12, 2024
Decision date: November 8, 2024
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary 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

Other 510(k)s with product code DYB

510(k)	Device	Applicant	Decision
K253526	NAMIC Dilator and SheathDYB · Traditional	Medline Industries, LP	07/29/2026SE
K261529	Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/…DYB · Traditional	Hartman Medical Group, LLC	07/06/2026SE
K261242	SimplGuideDYB · Traditional	Pendracare	06/25/2026SE
K261950	Health Line Tearaway IntroducerDYB · Traditional	Health Line International Corporation	06/22/2026SE
K261492	FieldFlex Steerable SheathDYB · Special	CenterPoint Systems, LLC	06/05/2026SE
K260606	Echo Large Bore Introducer SheathDYB · Traditional	Echo Medical, LLC	04/29/2026SE
K254248	Introducer Sheath SetDYB · Traditional	Cardiocycle Medical(Suzhou) Co., Ltd.	04/23/2026SE
K254279	Edwards eSheath+ introducer setDYB · Traditional	Edwards Lifesciences	04/17/2026SE
K260091	Aventus Introducer SheathDYB · Traditional	Inquis Medical	04/13/2026SE
K260839	Protaryx Transseptal Puncture Device (PTX2-001)DYB · Traditional	Protaryx Medical, Inc.	04/10/2026SE

Questions and answers

When was Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090) cleared by the FDA?

Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090) (K242756) received a 510(k) decision of Substantially Equivalent on November 8, 2024, 57 days after the submission was received.

What is the product code of K242756?

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