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FDA 510(k)

HALO ABLATION CATHETER

K-Number: K083737 · 2009-02-10

ApplicantBarrx Medical, Incorporated
Decision Date2009-02-10
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HALO ABLATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Barrx Medical, Incorporated. It received FDA 510(k) clearance on 2009-02-10 under 510(k) number K083737. 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 HALO ABLATION CATHETER?

HALO ABLATION CATHETER is a medical device that received FDA 510(k) clearance on 2009-02-10. The listed applicant is Barrx Medical, Incorporated. The 510(k) number is K083737.

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

HALO ABLATION CATHETER received FDA 510(k) clearance on 2009-02-10, under 510(k) number K083737.

Who is the listed applicant for HALO ABLATION CATHETER?

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

What is the FDA product code for HALO ABLATION CATHETER?

The FDA product code for HALO ABLATION CATHETER is GEI.

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Other records listing Barrx Medical, Incorporated 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.

K093855HALO 360 & SIZING BALLOON, MODEL 3441CK093008HALO ABLATION CATHETER, MODEL 90-9100K092487HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230AK083711MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34K082202HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230BK080557BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS

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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

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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