Cleared Traditional

Sensus Healthcare TVM Balloon Applicator

K190255 · Sensus Healthcare, Inc. · Radiology

Feb 2019

Decision

14d

Days

Class 2

Risk

About This 510(k) Submission

K190255 is an FDA 510(k) clearance for the Sensus Healthcare TVM Balloon Applicator, a System, Therapeutic, X-ray (Class II — Special Controls, product code JAD), submitted by Sensus Healthcare, Inc. (Boca Raton, US). The FDA issued a Cleared decision on February 21, 2019, 14 days after receiving the submission on February 7, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5900.

Submission Details

510(k) Number	K190255 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 07, 2019
Decision Date	February 21, 2019
Days to Decision	14 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF