Device Classification Name |
System, Hypothermia, Intravenous, Cooling
|
510(k) Number |
K223746 |
Device Name |
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console |
Applicant |
Zoll Circulation, Inc. |
2000 Ringwood Avenue |
San Jose,
CA
95131
|
|
Applicant Contact |
Brian Robey |
Correspondent |
Zoll Circulation, Inc. |
2000 Ringwood Avenue |
San Jose,
CA
95131
|
|
Correspondent Contact |
Brian Robey |
Regulation Number | 870.5900
|
Classification Product Code |
|
Date Received | 12/14/2022 |
Decision Date | 01/13/2023 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|