ComboCath OTW PTA Dilatation Catheter

Q: What is the product code of K150452?

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) K150452 · Summa Therapeutics, LLC

Substantially Equivalent

510(k) numberK150452

Submission

Device name: ComboCath OTW PTA Dilatation Catheter
Applicant: Summa Therapeutics, LLC
Mountain View, CA, US
Received: February 20, 2015
Decision date: August 13, 2015
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

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

510(k)	Device	Applicant	Decision
K260304	WAVE PTA Balloon CatheterLIT · Traditional	WAVE Medical AG	05/20/2026SE
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
K241740	Finesse Injectable PTA Balloon Dilatation CatheterLIT · Special	07/16/2024SE
K230263	Finesse Injectable PTA Balloon Dilatation CatheterLIT · Traditional	05/26/2023SE

Questions and answers

When was ComboCath OTW PTA Dilatation Catheter cleared by the FDA?

ComboCath OTW PTA Dilatation Catheter (K150452) received a 510(k) decision of Substantially Equivalent on August 13, 2015, 174 days after the submission was received.

What is the product code of K150452?

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