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FDA 510(k)

XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter

K-Number: K232258 · 2024-06-17

ApplicantTransit Scientific, LLC
Decision Date2024-06-17
Product CodePNO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

XO Constrain™ Percutaneous Transluminal Angioplasty Constraining 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 2024-06-17 under 510(k) number K232258. 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 Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter?

XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter is a medical device that received FDA 510(k) clearance on 2024-06-17. The listed applicant is Transit Scientific, LLC. The 510(k) number is K232258.

When did XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter receive FDA 510(k) clearance?

XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter received FDA 510(k) clearance on 2024-06-17, under 510(k) number K232258.

Who is the listed applicant for XO Constrain™ Percutaneous Transluminal Angioplasty Constraining 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 Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter?

The FDA product code for XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter is PNO.

Related Clinical Trials

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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.

K231821XO 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,)K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP CatheterK214107XO 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.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.K232207D·Kutting™ PTA Scoring Balloon Dilatation CatheterDk Medical Technology 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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