FDA 510(k) Applications Submitted by ZOLL Circulation, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K221700 |
06/13/2022 |
AutoPulse NXT Resuscitation System |
ZOLL Circulation, Inc. |
| K223746 |
12/14/2022 |
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 |
Zoll Circulation, Inc. |
| K213031 |
09/21/2021 |
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console |
Zoll Circulation, Inc. |
| K150046 |
01/12/2015 |
Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter |
Zoll Circulation, Inc. |
| K153226 |
11/06/2015 |
Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit |
ZOLL CIRCULATION, INC. |
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