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FDA 510(k)

Chocolate PTA Balloon Catheter

K-Number: K213631 · 2021-12-15

ApplicantMedtronic, Inc.
Decision Date2021-12-15
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Chocolate PTA Balloon Catheter is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2021-12-15 under approval number K213631. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Chocolate PTA Balloon Catheter?

Chocolate PTA Balloon Catheter is a medical device that received FDA 510(k) clearance on 2021-12-15. It is manufactured by Medtronic, Inc.. The 510(k) number is K213631.

When was Chocolate PTA Balloon Catheter approved by the FDA?

Chocolate PTA Balloon Catheter received FDA 510(k) clearance on 2021-12-15, under approval number K213631.

What company makes Chocolate PTA Balloon Catheter?

Chocolate PTA Balloon Catheter is manufactured by Medtronic, Inc..

What is the FDA product code for Chocolate PTA Balloon Catheter?

The FDA product code for Chocolate PTA Balloon Catheter is LIT.

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Related Devices (Code: LIT)

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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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