RAIN Sheath Tibial Pedal Introducer

Q: What is the product code of K230704?

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

FDA 510(k) K230704 · Cordis US Corp

Substantially Equivalent

510(k) numberK230704

Submission

Device name: RAIN Sheath Tibial Pedal Introducer
Applicant: Cordis US Corp
Miami Lakes, FL, US
Received: March 14, 2023
Decision date: April 24, 2023
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

More from Protaryx Medical, Inc.

510(k)	Device	Decision
K233637	Cordis BRITECROSS Support CatheterDQY · Traditional	06/28/2024SE
K232573	INFINITI Ambi Angiographic CatheterDQO · Traditional	11/21/2023SE
K221832	SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation CatheterLIT · Traditional	08/22/2022SE

Questions and answers

When was RAIN Sheath Tibial Pedal Introducer cleared by the FDA?

RAIN Sheath Tibial Pedal Introducer (K230704) received a 510(k) decision of Substantially Equivalent on April 24, 2023, 41 days after the submission was received.

What is the product code of K230704?

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

RAIN Sheath Tibial Pedal Introducer