FDA 510(k) Premarket Notification K143738: DSS Sinusplasty Balloon Catheter

Submission Details & Decision

Normalized public record details for 510(k) notification K143738.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K143738

Applicant / Sponsor

Intuit Medical Products, LLC

Device Name

DSS Sinusplasty Balloon Catheter

Product Code

LRC

Decision Date

2015-08-27

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Ear, Nose, Throat (EN)

Clearance Type

Traditional

Third Party Flag

Date Received

2014-12-30

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