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FDA 510(k)

Sensus Healthcare TVM Balloon Applicator

K-Number: K190255 · 2019-02-21

ApplicantSensus Healthcare, Inc.
Decision Date2019-02-21
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Sensus Healthcare TVM Balloon Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Sensus Healthcare, Inc.. It received FDA 510(k) clearance on 2019-02-21 under 510(k) number K190255. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sensus Healthcare TVM Balloon Applicator?

Sensus Healthcare TVM Balloon Applicator is a medical device that received FDA 510(k) clearance on 2019-02-21. The listed applicant is Sensus Healthcare, Inc.. The 510(k) number is K190255.

When did Sensus Healthcare TVM Balloon Applicator receive FDA 510(k) clearance?

Sensus Healthcare TVM Balloon Applicator received FDA 510(k) clearance on 2019-02-21, under 510(k) number K190255.

Who is the listed applicant for Sensus Healthcare TVM Balloon Applicator?

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

What is the FDA product code for Sensus Healthcare TVM Balloon Applicator?

The FDA product code for Sensus Healthcare TVM Balloon Applicator is JAD.

Other records listing Sensus Healthcare, 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.

K182665Sensus TPS WorkstationK182641Sensus IORT SystemK173425SRT-100+

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.K182641Sensus IORT SystemSensus Healthcare, Inc.K173425SRT-100+Sensus 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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