FDA 510(k) Applications Submitted by Carter Navarro
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K050191 |
01/27/2005 |
MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE |
BECTON DICKINSON & CO. |
| K060375 |
02/13/2006 |
BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166 |
BD Biosciences |
| K211030 |
04/06/2021 |
EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor |
Boston Scientific Corporation |
| K231533 |
05/26/2023 |
Habib EndoHPB |
Boston Scientific Corporation |
| K181439 |
06/01/2018 |
SpyGlass DS and DS II Direct Visualization System |
Boston Scientific Corporation |
| K222014 |
07/08/2022 |
EXALT Model B Single-Use Bronchoscope |
Boston Scientific Corporation |
| K062087 |
07/24/2006 |
BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 |
BD Biosciences |
| K082174 |
08/01/2008 |
Y-ADAPTER |
ASTHMATX, INC. |
| K142922 |
10/08/2014 |
SpyGlass DS Direct Visualization System |
BOSTON SCIENTIFIC CORPORATION |
| K193202 |
11/20/2019 |
EXALT Model D Single-Use Duodenoscope, EXALT Controller |
Boston Scientific Corporation |
| K183636 |
12/26/2018 |
SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller |
Boston Scientific Corporation |
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