FDA.reportPublic FDA data

510(k) K201246

Device
PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)
Applicant
Qualimed USA, LLC
510(k) number
K201246
Product code
LIT
Decision
Substantially Equivalent (SESE)
Decision date
2021-08-03
Date received
2020-05-08
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
Manfred Gulcher
Address
1800 Camden Rd., Suite 107 (P.O Box 252) Charlotte NC US 28203 28203

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
K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.2025-02-27
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