FDA 510(k) Applications Submitted by JAMES P GARVEY, II
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K132433 |
08/05/2013 |
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE |
ACCLARENT, INC. |
| K051271 |
05/17/2005 |
OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR |
NELLCOR PURITAN BENNETT, INC. |
| K140160 |
01/22/2014 |
RELIEVA SCOUT SINUS DILATION SYSTEM |
ACCLARENT, INC. |
| K161698 |
06/20/2016 |
Relieva UltirraNav Sinus Balloon Catheter |
ACCLARENT, INC. |
| K153341 |
11/19/2015 |
Relieva Scout Multi-Sinus Dilation System |
ACCLARENT, INC. |
| K173628 |
11/24/2017 |
Acclarent ENT Navigation System |
Acclarent, Inc |
| DEN150056 |
12/07/2015 |
Acclarent Aera Eustachian Tube Balloon Dilation System |
ACCLARENT, INC. |
| K150172 |
01/26/2015 |
ACCLARENT SE Inflation Device |
ACCLARENT, INC. |
| K171687 |
06/07/2017 |
Relieva SpinPlus Nav Balloon Sinuplasty System |
Acclarent, Inc. |
| K171761 |
06/14/2017 |
ACCLARENT AERA Eustachian Tube Balloon Dilation System |
Acclarent, Inc. |
| K182083 |
08/02/2018 |
Catalys Precision Laser System |
AMO Manufacturing USA, LLC |
|
|
