FDA 510(k)

BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS

K-Number: K080557 · 2008-04-02

Decision Date2008-04-02

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS 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 2008-04-02 under 510(k) number K080557. 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 BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS?

BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS is a medical device that received FDA 510(k) clearance on 2008-04-02. The listed applicant is Barrx Medical, Incorporated. The 510(k) number is K080557.

When did BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS receive FDA 510(k) clearance?

BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS received FDA 510(k) clearance on 2008-04-02, under 510(k) number K080557.

Who is the listed applicant for BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS?

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 BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS?

The FDA product code for BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS is GEI.

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Other records listing Barrx Medical, Incorporated as applicant

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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.