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FDA 510(k)

AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E

K-Number: K090914 · 2009-07-16

ApplicantXoft, Inc.
Decision Date2009-07-16
Product CodeJAD
Advisory CommitteeRA
DecisionUnknown

Device Summary

AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E is the device name listed in this FDA 510(k) record. The listed applicant is Xoft, Inc.. It received FDA 510(k) clearance on 2009-07-16 under 510(k) number K090914. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E?

AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E is a medical device that received FDA 510(k) clearance on 2009-07-16. The listed applicant is Xoft, Inc.. The 510(k) number is K090914.

When did AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E receive FDA 510(k) clearance?

AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E received FDA 510(k) clearance on 2009-07-16, under 510(k) number K090914.

Who is the listed applicant for AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E?

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

What is the FDA product code for AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E?

The FDA product code for AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E is JAD.

Related Clinical Trials

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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Other records listing Xoft, 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.

K090417AXXENT FLEXISHIELD MINIK083734AXXENT SURFACE APPLICATOR, MODEL 710257K072616AXXENT VAGINAL APPLICATORK072683AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMK050843AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

Related Devices (Code: JAD)

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.

K250692GentleBeam (GB1000)Voxel Ray Solutions, LLCK241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)Carl Zeiss Meditec, AGK230611X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)Xstrahl, Ltd.K213942EsteyaNucletron B.V.K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc.K182641Sensus IORT SystemSensus Healthcare, Inc.

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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