FDA 510(k)

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

K-Number: K221986 · 2022-10-18

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 a medical device manufactured by Transit Scientific, LLC. It received FDA 510(k) clearance on 2022-10-18 under approval 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. It is manufactured by Transit Scientific, LLC. The 510(k) number is K221986.

When was XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter approved by the FDA?

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

What company makes 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 manufactured by Transit Scientific, LLC.

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.

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Other Devices by Transit Scientific, LLC

K210322XO Cross Support 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,) K232258XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter

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.