FDA 510(k) Applications Submitted by Jen Correa
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K200630 |
03/10/2020 |
Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags |
Medtronic, Inc. |
| K201118 |
04/27/2020 |
Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level |
Medtronic, Inc. |
| K181807 |
07/06/2018 |
Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device) |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| K162539 |
09/12/2016 |
Solitaire 2 Revascularization Device |
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
| K133853 |
12/19/2013 |
VIEWFLEX XTRA ICE CATHETER |
IRVINE BIOMEDICAL, INC. A ST.JUDE MEDICAL COMPANY |
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