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FDA 510(k)

Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen

K-Number: K192125 · 2019-11-04

ApplicantAtriCure, Inc.
Decision Date2019-11-04
Product CodeOCL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen is a medical device manufactured by AtriCure, Inc.. It received FDA 510(k) clearance on 2019-11-04 under approval number K192125. The device is classified under product code OCL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen?

Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen is a medical device that received FDA 510(k) clearance on 2019-11-04. It is manufactured by AtriCure, Inc.. The 510(k) number is K192125.

When was Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen approved by the FDA?

Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen received FDA 510(k) clearance on 2019-11-04, under approval number K192125.

What company makes Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen?

Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen is manufactured by AtriCure, Inc..

What is the FDA product code for Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen?

The FDA product code for Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen is OCL.

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Related Devices (Code: OCL)

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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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