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FDA 510(k)

Chocolate XD PTCA Balloon Catheter

K-Number: K153682 · 2016-06-23

ApplicantTrireme Medical, LLC
Decision Date2016-06-23
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Chocolate XD PTCA Balloon Catheter is a medical device manufactured by Trireme Medical, LLC. It received FDA 510(k) clearance on 2016-06-23 under approval number K153682. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Chocolate XD PTCA Balloon Catheter?

Chocolate XD PTCA Balloon Catheter is a medical device that received FDA 510(k) clearance on 2016-06-23. It is manufactured by Trireme Medical, LLC. The 510(k) number is K153682.

When was Chocolate XD PTCA Balloon Catheter approved by the FDA?

Chocolate XD PTCA Balloon Catheter received FDA 510(k) clearance on 2016-06-23, under approval number K153682.

What company makes Chocolate XD PTCA Balloon Catheter?

Chocolate XD PTCA Balloon Catheter is manufactured by Trireme Medical, LLC.

What is the FDA product code for Chocolate XD PTCA Balloon Catheter?

The FDA product code for Chocolate XD PTCA Balloon Catheter is LOX.

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Other Devices by Trireme Medical, LLC

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Related Devices (Code: LOX)

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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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