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FDA 510(k)

Ablamap® System

K-Number: K230008 · 2023-06-08

ApplicantAblacon, Inc.
Decision Date2023-06-08
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Ablamap® System is a medical device manufactured by Ablacon, Inc.. It received FDA 510(k) clearance on 2023-06-08 under approval number K230008. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ablamap® System?

Ablamap® System is a medical device that received FDA 510(k) clearance on 2023-06-08. It is manufactured by Ablacon, Inc.. The 510(k) number is K230008.

When was Ablamap® System approved by the FDA?

Ablamap® System received FDA 510(k) clearance on 2023-06-08, under approval number K230008.

What company makes Ablamap® System?

Ablamap® System is manufactured by Ablacon, Inc..

What is the FDA product code for Ablamap® System?

The FDA product code for Ablamap® System is DQK.

Other Devices by Ablacon, Inc.

K203084Ablamap Software K223666Ablacath™ Mapping Catheter

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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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