FDA 510(k)

HALO 360 & SIZING BALLOON, MODEL 3441C

K-Number: K093855 · 2010-01-15

Decision Date2010-01-15

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

HALO 360 & SIZING BALLOON, MODEL 3441C 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 2010-01-15 under 510(k) number K093855. 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 360 & SIZING BALLOON, MODEL 3441C?

HALO 360 & SIZING BALLOON, MODEL 3441C is a medical device that received FDA 510(k) clearance on 2010-01-15. The listed applicant is Barrx Medical, Incorporated. The 510(k) number is K093855.

When did HALO 360 & SIZING BALLOON, MODEL 3441C receive FDA 510(k) clearance?

HALO 360 & SIZING BALLOON, MODEL 3441C received FDA 510(k) clearance on 2010-01-15, under 510(k) number K093855.

Who is the listed applicant for HALO 360 & SIZING BALLOON, MODEL 3441C?

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 360 & SIZING BALLOON, MODEL 3441C?

The FDA product code for HALO 360 & SIZING BALLOON, MODEL 3441C is GEI.

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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.