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FDA 510(k)

OPTRELL Mapping Catheter with TRUEref Technology

K-Number: K211438 · 2022-03-18

ApplicantBiosense Webster, Inc.
Decision Date2022-03-18
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 2022-03-18 under approval number K211438. 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 2022-03-18. It is manufactured by Biosense Webster, Inc.. The 510(k) number is K211438.

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

OPTRELL Mapping Catheter with TRUEref Technology received FDA 510(k) clearance on 2022-03-18, under approval number K211438.

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.

Related Clinical Trials

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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.

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