Finesse Injectable™ PTA Balloon Dilatation Catheter

FDA 510(k) K241740 · Summa Therapeutics

Substantially Equivalent

510(k) numberK241740

Submission

Device name
Finesse Injectable™ PTA Balloon Dilatation Catheter
Applicant
Summa Therapeutics
Cambridge, MA, US
Received
June 17, 2024
Decision date
July 16, 2024
Decision
Substantially Equivalent (SESE)
Type
Special 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)DeviceApplicantDecision
K260304WAVE PTA Balloon CatheterLIT · Traditional WAVE Medical AG05/20/2026SE
K252512Armada™ 14 NC PTA CatheterLIT · Traditional Abbott Medical02/13/2026SE
K251915Amethyst HP PTA OTW 0.035 CatheterLIT · Traditional Natec Medical , Ltd.12/18/2025SE
K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…LIT · Special Biotronik, Inc.04/04/2025SE
K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon…LIT · Traditional Brosmed Medical Co., Ltd.02/27/2025SE
K241040Amethyst HP PTA OTW 0.035 CatheterLIT · Traditional Natec Medical , Ltd.12/18/2024SE
K242419018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterLIT · Traditional Creagh Medical Ltd. Dba Surmodics, Inc.11/15/2024SE
K241711Oscar Peripheral Multifunctional Catheter systemLIT · Special Biotronik, Inc.07/11/2024SE
K241683Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling™…LIT · Special Boston Scientific Corporation07/10/2024SE
K241025JADE PLUS PTA Balloon Dilatation CatheterLIT · Traditional OrbusNeich Medical (Shenzhen) Co., Ltd.06/11/2024SE

More from OrbusNeich Medical (Shenzhen) Co., Ltd.

510(k)DeviceDecision
K230263Finesse™ Injectable PTA Balloon Dilatation CatheterLIT · Traditional 05/26/2023SE
K150452ComboCath OTW PTA Dilatation CatheterLIT · Traditional 08/13/2015SE

Questions and answers

When was Finesse Injectable™ PTA Balloon Dilatation Catheter cleared by the FDA?

Finesse Injectable™ PTA Balloon Dilatation Catheter (K241740) received a 510(k) decision of Substantially Equivalent on July 16, 2024, 29 days after the submission was received.

What is the product code of K241740?

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