FDA.report

510(k) K161427

Device
Pirouette 035
Applicant
ArraVasc Limited
510(k) number
K161427
Product code
LIT  
Decision
Substantially Equivalent (SESE)
Decision date
2016-07-30
Date received
2016-05-23
Regulation
870.1250
Classification name
Catheter, Angioplasty, Peripheral, Transluminal
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Aoife Donoghue
Address
2 Ballybrit Business Park Galway IE

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
05397132007317AdvocateARRAVASC LIMITED2016-09-20
05397132007331AdvocateARRAVASC LIMITED2016-09-20
05397132007348AdvocateARRAVASC LIMITED2016-09-20
05397132007256AdvocateARRAVASC LIMITED2016-09-20
05397132007232AdvocateARRAVASC LIMITED2016-09-20
05397132007324AdvocateARRAVASC LIMITED2016-09-20
05397132007249AdvocateARRAVASC LIMITED2016-09-20
05397132007201AdvocateARRAVASC LIMITED2016-09-20
05397132007300AdvocateARRAVASC LIMITED2016-09-20
05397132007294AdvocateARRAVASC LIMITED2016-09-20
05397132007225AdvocateARRAVASC LIMITED2016-09-20
05397132007270AdvocateARRAVASC LIMITED2016-09-20
05397132007287AdvocateARRAVASC LIMITED2016-09-20
05397132007263AdvocateARRAVASC LIMITED2016-09-20
05397132007218AdvocateARRAVASC LIMITED2016-09-20
05397132007379AdvocateARRAVASC LIMITED2016-09-14
05397132007454AdvocateARRAVASC LIMITED2016-09-14
05397132007447AdvocateARRAVASC LIMITED2016-09-14
05397132007355AdvocateARRAVASC LIMITED2016-09-14
05397132007478AdvocateARRAVASC LIMITED2016-09-14
05397132007461AdvocateARRAVASC LIMITED2016-09-14
05397132007386AdvocateARRAVASC LIMITED2016-09-14
05397132007423AdvocateARRAVASC LIMITED2016-09-14
05397132007416AdvocateARRAVASC LIMITED2016-09-14
05397132007539AdvocateARRAVASC LIMITED2016-09-14
05397132007430AdvocateARRAVASC LIMITED2016-09-14
05397132007522AdvocateARRAVASC LIMITED2016-09-14
05397132007485AdvocateARRAVASC LIMITED2016-09-14
05397132007393AdvocateARRAVASC LIMITED2016-09-14
05397132007362AdvocateARRAVASC LIMITED2016-09-14

Other 510(k) Records For Product Code LIT  

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

Legacy Summary

summary

FDA Review

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