FDA 510(k)

XO CROSS CORONARY Support Catheter

K-Number: K214107 · 2022-04-11

Decision Date2022-04-11

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

XO CROSS CORONARY Support Catheter is a medical device manufactured by Transit Scientific, LLC. It received FDA 510(k) clearance on 2022-04-11 under approval number K214107. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XO CROSS CORONARY Support Catheter?

XO CROSS CORONARY Support Catheter is a medical device that received FDA 510(k) clearance on 2022-04-11. It is manufactured by Transit Scientific, LLC. The 510(k) number is K214107.

When was XO CROSS CORONARY Support Catheter approved by the FDA?

XO CROSS CORONARY Support Catheter received FDA 510(k) clearance on 2022-04-11, under approval number K214107.

What company makes XO CROSS CORONARY Support Catheter?

XO CROSS CORONARY Support Catheter is manufactured by Transit Scientific, LLC.

What is the FDA product code for XO CROSS CORONARY Support Catheter?

The FDA product code for XO CROSS CORONARY Support Catheter is DQY.

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Other Devices by Transit Scientific, LLC

K210322XO Cross Support Catheter K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP 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

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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.