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FDA 510(k)

HALO60 ABLATION CATHETER

K-Number: K112454 · 2012-01-05

ApplicantBarrx Medical, Inc.
Decision Date2012-01-05
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HALO60 ABLATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Barrx Medical, Inc.. It received FDA 510(k) clearance on 2012-01-05 under 510(k) number K112454. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HALO60 ABLATION CATHETER?

HALO60 ABLATION CATHETER is a medical device that received FDA 510(k) clearance on 2012-01-05. The listed applicant is Barrx Medical, Inc.. The 510(k) number is K112454.

When did HALO60 ABLATION CATHETER receive FDA 510(k) clearance?

HALO60 ABLATION CATHETER received FDA 510(k) clearance on 2012-01-05, under 510(k) number K112454.

Who is the listed applicant for HALO60 ABLATION CATHETER?

The FDA 510(k) record lists Barrx Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HALO60 ABLATION CATHETER?

The FDA product code for HALO60 ABLATION CATHETER is GEI.

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Other records listing Barrx Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K120431HALO90 ULTRA ABLATION CATHETERK101111HALO ABLATION CATHETER MODEL 90-9100, HALO90 ULTRA ABLATION CATHETER MODEL 90-9200

Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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