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FDA 510(k)

OPN NC PTCA Dilatation Catheter

K-Number: K212393 · 2022-03-14

ApplicantSis Medical AG
Decision Date2022-03-14
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OPN NC PTCA Dilatation Catheter is a medical device manufactured by Sis Medical AG. It received FDA 510(k) clearance on 2022-03-14 under approval number K212393. 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 OPN NC PTCA Dilatation Catheter?

OPN NC PTCA Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2022-03-14. It is manufactured by Sis Medical AG. The 510(k) number is K212393.

When was OPN NC PTCA Dilatation Catheter approved by the FDA?

OPN NC PTCA Dilatation Catheter received FDA 510(k) clearance on 2022-03-14, under approval number K212393.

What company makes OPN NC PTCA Dilatation Catheter?

OPN NC PTCA Dilatation Catheter is manufactured by Sis Medical AG.

What is the FDA product code for OPN NC PTCA Dilatation Catheter?

The FDA product code for OPN NC PTCA Dilatation Catheter is LOX.

Related Clinical Trials

NCT07397390 an Observational Study Evaluting the Effectiveness and Safety of DKutting LL Noval Scoring Balloon Angioplasty for Vessel Preparation Facilitated by IVUS on the Lower Limb Ischemia Patients With Calcified Lesions ENROLLING_BY_INVITATION NCT05509296 Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease COMPLETED

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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