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FDA 510(k)

XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter

K-Number: K221986 · 2022-10-18

ApplicantTransit Scientific, LLC
Decision Date2022-10-18
Product CodePNO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Transit Scientific, LLC. It received FDA 510(k) clearance on 2022-10-18 under 510(k) number K221986. The device is classified under product code PNO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter?

XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter is a medical device that received FDA 510(k) clearance on 2022-10-18. The listed applicant is Transit Scientific, LLC. The 510(k) number is K221986.

When did XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter receive FDA 510(k) clearance?

XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter received FDA 510(k) clearance on 2022-10-18, under 510(k) number K221986.

Who is the listed applicant for XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter?

The FDA 510(k) record lists Transit Scientific, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter?

The FDA product code for XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter is PNO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07397390an Observational Study Evaluting the Effectiveness and Safety of DKutting LL Noval Scoring Balloon Angioplasty for Vessel Preparation Facilitated by IVUS on the Lower Limb Ischemia Patients With Calcified LesionsENROLLING_BY_INVITATIONNCT05731700CVT-ISR First in Human Trial for Coronary In-Stent RestenosisCOMPLETEDNCT05734157CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal ArteryCOMPLETEDNCT06330493AcoArt Litos PCB Below-the-knee Global TrialTERMINATEDNCT03466151RESOLUTE ONYX China RCT StudyACTIVE_NOT_RECRUITINGNCT03471845RESOLUTE ONYX China Single Arm StudyACTIVE_NOT_RECRUITING

Other records listing Transit Scientific, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterK231821XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)K214107XO CROSS CORONARY Support CatheterK210322XO Cross Support CatheterK193495XO Score Percutaneous Transluminal Angioplasty Scoring CatheterK193420XO Cross Support Catheter

View all 7 devices →

Related Devices (Code: PNO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260012UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc.K243944Aperta NSE PTA Balloon Dilatation CatheterGoodman Co., Ltd.K242254D·Kutting™ LL Peripheral Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.K241478Tri-Wedge PTA Scoring Balloon Dilatation CatheterBrosmed Medical Co., Ltd.K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLCK232013Aperta 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.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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