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FDA 510(k)

PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)

K-Number: K201246 · 2021-08-03

ApplicantQualimed USA, LLC
Decision Date2021-08-03
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ) is a medical device manufactured by Qualimed USA, LLC. It received FDA 510(k) clearance on 2021-08-03 under approval number K201246. 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 PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)?

PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ) is a medical device that received FDA 510(k) clearance on 2021-08-03. It is manufactured by Qualimed USA, LLC. The 510(k) number is K201246.

When was PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ) approved by the FDA?

PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ) received FDA 510(k) clearance on 2021-08-03, under approval number K201246.

What company makes PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)?

PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ) is manufactured by Qualimed USA, LLC.

What is the FDA product code for PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)?

The FDA product code for PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ) is LIT.

Related Clinical Trials

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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.

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