FDA 510(k)

OPTRELL Mapping Catheter with TRUEref Technology

K-Number: K230253 · 2023-03-02

Decision Date2023-03-02

Product CodeMTD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

OPTRELL Mapping Catheter with TRUEref Technology is a medical device manufactured by Biosense Webster, Inc.. It received FDA 510(k) clearance on 2023-03-02 under approval number K230253. The device is classified under product code MTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTRELL Mapping Catheter with TRUEref Technology?

OPTRELL Mapping Catheter with TRUEref Technology is a medical device that received FDA 510(k) clearance on 2023-03-02. It is manufactured by Biosense Webster, Inc.. The 510(k) number is K230253.

When was OPTRELL Mapping Catheter with TRUEref Technology approved by the FDA?

OPTRELL Mapping Catheter with TRUEref Technology received FDA 510(k) clearance on 2023-03-02, under approval number K230253.

What company makes OPTRELL Mapping Catheter with TRUEref Technology?

OPTRELL Mapping Catheter with TRUEref Technology is manufactured by Biosense Webster, Inc..

What is the FDA product code for OPTRELL Mapping Catheter with TRUEref Technology?

The FDA product code for OPTRELL Mapping Catheter with TRUEref Technology is MTD.

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Related Devices (Code: MTD)

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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.