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FDA 510(k)

Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter

K-Number: K190980 · 2019-07-01

ApplicantInnovative Health, LLC
Decision Date2019-07-01
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter is a medical device manufactured by Innovative Health, LLC. It received FDA 510(k) clearance on 2019-07-01 under approval number K190980. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter?

Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter is a medical device that received FDA 510(k) clearance on 2019-07-01. It is manufactured by Innovative Health, LLC. The 510(k) number is K190980.

When was Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter approved by the FDA?

Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter received FDA 510(k) clearance on 2019-07-01, under approval number K190980.

What company makes Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter?

Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter is manufactured by Innovative Health, LLC.

What is the FDA product code for Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter?

The FDA product code for Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter is DRF.

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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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