Device Listing 1300941937

Listing Summary#

Listing key
1300941937
Premarket submission
K213031
Device
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
Applicant
Zoll Circulation, Inc.
Product code
NCX
Decision date
2021-12-20