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FDA 510(k)

Infinity Angioplasty Balloon Catheter

K-Number: K192399 · 2020-05-20

ApplicantInfinity Angioplasty Balloon Company, LLC
Decision Date2020-05-20
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Infinity Angioplasty Balloon Catheter is a medical device manufactured by Infinity Angioplasty Balloon Company, LLC. It received FDA 510(k) clearance on 2020-05-20 under approval number K192399. 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 Infinity Angioplasty Balloon Catheter?

Infinity Angioplasty Balloon Catheter is a medical device that received FDA 510(k) clearance on 2020-05-20. It is manufactured by Infinity Angioplasty Balloon Company, LLC. The 510(k) number is K192399.

When was Infinity Angioplasty Balloon Catheter approved by the FDA?

Infinity Angioplasty Balloon Catheter received FDA 510(k) clearance on 2020-05-20, under approval number K192399.

What company makes Infinity Angioplasty Balloon Catheter?

Infinity Angioplasty Balloon Catheter is manufactured by Infinity Angioplasty Balloon Company, LLC.

What is the FDA product code for Infinity Angioplasty Balloon Catheter?

The FDA product code for Infinity Angioplasty Balloon Catheter is 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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