FDA 510(k)

Chocolate PTA Balloon Catheter

K-Number: K213631 · 2021-12-15

Decision Date2021-12-15

Product CodeLIT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Chocolate PTA Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2021-12-15 under 510(k) 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. The listed applicant is Medtronic, Inc.. The 510(k) number is K213631.

When did Chocolate PTA Balloon Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Chocolate PTA Balloon Catheter?

The FDA 510(k) record lists Medtronic, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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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.