FDA.reportPublic FDA data

510(k) K221986

Device
XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter
Applicant
Transit Scientific, LLC
510(k) number
K221986
Product code
PNO
Decision
Substantially Equivalent (SESE)
Decision date
2022-10-18
Date received
2022-07-06
Regulation
870.1250
Classification name
Catheter, Percutaneous, Cutting/Scoring
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jennifer Arnold
Address
2757 S. 300 W, Suite E Salt Lake City UT US 84115 84115

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PNO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260012UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc.2026-02-04
K243944Aperta NSE PTA Balloon Dilatation CatheterGoodman Co., Ltd.2025-04-22
K242254D·Kutting™ LL Peripheral Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.2025-04-21
K241478Tri-Wedge PTA Scoring Balloon Dilatation CatheterBrosmed Medical Co., Ltd.2024-10-22
K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLC2024-06-17
K232013Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)Goodman Co., Ltd.2024-03-28
K232207D·Kutting™ PTA Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.2024-03-07
K220704Serranator PTA Serration Balloon CatheterCagent Vascular, LLC2022-05-04
K213728Serranator PTA Serration Balloon CatheterCagent Vascular, LLC2021-12-15
K203437Serranator PTA Serration Balloon CatheterCagent Vascular, LLC2020-12-22
K202187FLEX Vessel Prep SystemVenturemed Group, Inc.2020-09-11
K193495XO Score Percutaneous Transluminal Angioplasty Scoring CatheterTransit Scientific2020-05-29
K193181Serranator PTA Serration Balloon CatheterCagent Vascular, LLC2020-04-15
K182713Scoreflex PTA Scoring Balloon CatheterOrbusneich Medical Trading, Inc.2019-06-11
K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard2017-09-22