FDA 510(k) Applications Submitted by Covidien, LLC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K180485 |
02/23/2018 |
Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender |
Covidien, llc |
| K192302 |
08/23/2019 |
Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter |
Covidien, llc |
| K213602 |
11/15/2021 |
Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit |
Covidien, llc |
| K200427 |
02/21/2020 |
Sonicision Cordless Ultrasonic Dissector |
Covidien, llc |
| K212301 |
07/23/2021 |
Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device |
Covidien, LLC |
| K141801 |
07/03/2014 |
HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM |
COVIDIEN, LLC |
| K193356 |
12/04/2019 |
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider |
Covidien, LLC |
| K203303 |
11/09/2020 |
Emprint SX Ablation Platform with Thermosphere Technology |
Covidien, LLC |
| K211561 |
05/20/2021 |
INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) |
Covidien, llc |
| K223158 |
10/07/2022 |
LigaSureÖ XP Maryland Jaw Sealer/Divider |
Covidien, llc |
| K180149 |
01/19/2018 |
Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide |
Covidien, llc |
| K180192 |
01/24/2018 |
Emprint Ablation Visualization Application |
Covidien, LLC |
| K182451 |
09/07/2018 |
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider |
Covidien, LLC |
| K200146 |
01/22/2020 |
HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor |
Covidien, llc |
| K171066 |
04/10/2017 |
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider |
Covidien, llc |
| K193056 |
11/01/2019 |
Puritan Bennett 980 Series Ventilator System |
Covidien, LLC |
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