FDA.report

510(k) K162316

Device
Pirouette 014
Applicant
ArraVasc Ltd
510(k) number
K162316
Product code
LIT  
Decision
Substantially Equivalent (SESE)
Decision date
2016-11-22
Date received
2016-08-18
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
05397132010461AdvocateARRAVASC LIMITED2018-03-02
05397132010683AdvocateARRAVASC LIMITED2018-03-02
05397132010744AdvocateARRAVASC LIMITED2018-03-01
05397132010591AdvocateARRAVASC LIMITED2018-03-01
05397132010614AdvocateARRAVASC LIMITED2018-03-01
05397132010621AdvocateARRAVASC LIMITED2018-03-01
05397132010638AdvocateARRAVASC LIMITED2018-03-01
05397132010645AdvocateARRAVASC LIMITED2018-03-01
05397132010652AdvocateARRAVASC LIMITED2018-03-01
05397132010669AdvocateARRAVASC LIMITED2018-03-01
05397132010676AdvocateARRAVASC LIMITED2018-03-01
05397132009229AdvocateARRAVASC LIMITED2018-03-01
05397132010706AdvocateARRAVASC LIMITED2018-03-01
05397132010713AdvocateARRAVASC LIMITED2018-03-01
05397132010720AdvocateARRAVASC LIMITED2018-03-01
05397132010737AdvocateARRAVASC LIMITED2018-03-01
05397132010898AdvocateARRAVASC LIMITED2018-03-01
05397132010751AdvocateARRAVASC LIMITED2018-03-01
05397132010768AdvocateARRAVASC LIMITED2018-03-01
05397132010775AdvocateARRAVASC LIMITED2018-03-01
05397132010782AdvocateARRAVASC LIMITED2018-03-01
05397132010799AdvocateARRAVASC LIMITED2018-03-01
05397132010805AdvocateARRAVASC LIMITED2018-03-01
05397132010812AdvocateARRAVASC LIMITED2018-03-01
05397132010829AdvocateARRAVASC LIMITED2018-03-01
05397132010836AdvocateARRAVASC LIMITED2018-03-01
05397132010843AdvocateARRAVASC LIMITED2018-03-01
05397132010850AdvocateARRAVASC LIMITED2018-03-01
05397132010867AdvocateARRAVASC LIMITED2018-03-01
05397132010874AdvocateARRAVASC LIMITED2018-03-01

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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