FDA 510(k) Applications Submitted by Jake Wolenberg
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K180169 |
01/22/2018 |
EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, |
Imperative Care Inc. |
| K150946 |
04/08/2015 |
FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm |
OSTIAL CORPORATION |
| K131450 |
05/20/2013 |
FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0 |
OSTIAL CORPORATION |
| K202182 |
08/04/2020 |
ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing |
Imperative Care Inc. |
| K152485 |
08/31/2015 |
FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm |
OSTIAL CORPORATION |
| K172716 |
09/08/2017 |
V2K Rinspiration System |
V2K Medical Inc. |
| K183043 |
11/02/2018 |
0.071ö ID MantaRay Reperfusion Catheter, 0.055ö ID MantaRay Reperfusion Catheter, 0.045ö ID MantaRay Reperfusion Catheter, 0.035ö ID MantaRay Reperfusion Catheter |
Imperative Care Inc. |
| K133861 |
12/19/2013 |
FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM |
OSTIAL CORPORATION |
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