Excel Y-Connector Cat. #E-201

Q: What is the product code of K884327?

The FDA product code is LIT – Catheter, Angioplasty, Peripheral, Transluminal, a Class II (moderate risk) device regulated under 21 CFR 870.1250.

FDA 510(k) K884327 · Medical Profiles, Inc.

Substantially Equivalent

510(k) numberK884327

Submission

Device name: Excel Y-Connector Cat. #E-201
Applicant: Medical Profiles, Inc.
Lavonia, MI, US
Received: October 14, 1988
Decision date: April 19, 1989
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: LIT – Catheter, Angioplasty, Peripheral, Transluminal
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.1250
Specialty: Cardiovascular

Other 510(k)s with product code LIT

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K252512	Armada 14 NC PTA CatheterLIT · Traditional	Abbott Medical	02/13/2026SE
K251915	Amethyst HP PTA OTW 0.035 CatheterLIT · Traditional	Natec Medical , Ltd.	12/18/2025SE
K250706	Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…LIT · Special	Biotronik, Inc.	04/04/2025SE
K243704	Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon…LIT · Traditional	Brosmed Medical Co., Ltd.	02/27/2025SE
K241040	Amethyst HP PTA OTW 0.035 CatheterLIT · Traditional	Natec Medical , Ltd.	12/18/2024SE
K242419	018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterLIT · Traditional	Creagh Medical Ltd. Dba Surmodics, Inc.	11/15/2024SE
K241740	Finesse Injectable PTA Balloon Dilatation CatheterLIT · Special	Summa Therapeutics	07/16/2024SE
K241711	Oscar Peripheral Multifunctional Catheter systemLIT · Special	Biotronik, Inc.	07/11/2024SE
K241683	Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling…LIT · Special	Boston Scientific Corporation	07/10/2024SE

More from Boston Scientific Corporation

510(k)	Device	Decision
K914378	Peripheral Intervenous CatheterFOZ · Traditional	05/20/1993SEKD
K883769	Excel Inflate-AidDXT · Traditional	12/01/1988SE

Questions and answers

When was Excel Y-Connector Cat. #E-201 cleared by the FDA?

Excel Y-Connector Cat. #E-201 (K884327) received a 510(k) decision of Substantially Equivalent on April 19, 1989, 187 days after the submission was received.

What is the product code of K884327?

The FDA product code is LIT – Catheter, Angioplasty, Peripheral, Transluminal, a Class II (moderate risk) device regulated under 21 CFR 870.1250.