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FDA 510(k)

Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled

K-Number: K200205 · 2020-05-13

ApplicantStryker Sustainability Solutions
Decision Date2020-05-13
Product CodeNLH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled is a medical device manufactured by Stryker Sustainability Solutions. It received FDA 510(k) clearance on 2020-05-13 under approval number K200205. The device is classified under product code NLH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled?

Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled is a medical device that received FDA 510(k) clearance on 2020-05-13. It is manufactured by Stryker Sustainability Solutions. The 510(k) number is K200205.

When was Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled approved by the FDA?

Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled received FDA 510(k) clearance on 2020-05-13, under approval number K200205.

What company makes Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled?

Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled is manufactured by Stryker Sustainability Solutions.

What is the FDA product code for Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled?

The FDA product code for Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled is NLH.

Related Clinical Trials

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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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