FDA.reportPublic FDA data

510(k) K243704

Device
Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter
Applicant
Brosmed Medical Co., Ltd.
510(k) number
K243704
Product code
LIT
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-27
Date received
2024-11-29
Regulation
870.1250
Classification name
Catheter, Angioplasty, Peripheral, Transluminal
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Crystal Lee
Address
15th Bldg., Smes Venture Park Songshan Lake Hi-Tech Industrial Development Zone Dongguan CN 523808 523808

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LIT#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260304WAVE PTA Balloon CatheterWAVE Medical AG2026-05-20
K252512Armada™ 14 NC PTA CatheterABBOTT MEDICAL2026-02-13
K251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.2025-12-18
K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterBiotronik, Inc.2025-04-04
K241040Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.2024-12-18
K242419018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterCreagh Medical Ltd. Dba Surmodics, Inc.2024-11-15
K241740Finesse Injectable™ PTA Balloon Dilatation CatheterSumma Therapeutics2024-07-16
K241711Oscar Peripheral Multifunctional Catheter systemBiotronik, Inc.2024-07-11
K241683Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031406020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031408020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031410020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031412020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031415020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H749390314Boston Scientific Corporation2024-07-10
K241025JADE PLUS PTA Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.2024-06-11
K231402HP PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.2023-12-20
K230263Finesse™ Injectable PTA Balloon Dilatation CatheterSumma Therapeutics, LLC2023-05-26
K214009D·Kaptain PTA High Pressure Balloon Dilatation CatheterDk Medical Technology Co., Ltd.2023-04-05
K230191Arise™ UHP Dilatation CatheterCreagh Medical, Ltd.2023-03-22
K222065Passeo-35 Xeo Peripheral Dilatation CatheterBiotronik, Inc.2023-02-16