FDA 510(k)

XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter

K-Number: K232258 · 2024-06-17

Decision Date2024-06-17

Product CodePNO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter is a medical device manufactured by Transit Scientific, LLC. It received FDA 510(k) clearance on 2024-06-17 under approval 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. It is manufactured by Transit Scientific, LLC. The 510(k) number is K232258.

When was XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter approved by the FDA?

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

What company makes XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter?

XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter is manufactured by Transit Scientific, LLC.

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.

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Related PubMed Literature

PMID: 25499024 Overview of the 2014 Food and Drug Administration Circulatory System Devices Panel meeting regarding the Lutonix® drug coated balloon. Cardiovascular revascularization medicine : including molecular interventions (2014)

Other Devices by Transit Scientific, LLC

K210322XO Cross Support Catheter K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter K214107XO CROSS CORONARY Support Catheter 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,)

Related Devices (Code: PNO)

K152789FLEX SCORING CATHETERVenturemed Group K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard K163420UltraScore Focused Force PTA BalloonBard Peripheral Vascular, Inc. K163380Serranator Alto PTA Serration Balloon CatheterCagent Vascular, LLC K182713Scoreflex PTA Scoring Balloon CatheterOrbusneich Medical Trading, Inc. K203437Serranator PTA Serration Balloon CatheterCagent Vascular, LLC

Official Source

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