XO 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, )

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K231821 ↗

FDA Product Code

KRA

Device Class

Class II

Regulation

21 CFR Part 870.1210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K214107 Active Cleared 11 Apr 2022

• XO Score Percutaneous Transluminal Angioplasty Scoring Catheter

  Class II

  FDA 510(k) K193495 Active Cleared 29 May 2020

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

  Class II

  FDA 510(k) K221986 Active Cleared 18 Oct 2022

• XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter

  Class II

  FDA 510(k) K232258 Active Cleared 17 Jun 2024

• XO Cross Support Catheter

  Class II

  FDA 510(k) K210322 Active Cleared 21 Oct 2021

• XO Cross Support Catheter

  Class II

  FDA 510(k) K193420 Active Cleared 6 May 2020