Atlas FDA

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

FDA 510(k) clearance K223746 · decided 2023-01-13

Clearance details

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.
Decision
Unknown
Date received
2022-12-14
Decision date
2023-01-13
Days to decision
30 days
Clearance type
Special
Product code
NCX
Device class
2
Regulation number
870.5900
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
San Jose, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console (K220008)Zoll Circulation, Inc.2022-06-02
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 (K213031)Zoll Circulation, Inc.2021-12-20
TEMPEDY (K152946)Seiratherm GmbH2016-09-15
Hypocore (K153162)Novocor Medical Systems, Inc.2016-05-24
Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit (K153226)Zoll Circulation, Inc.2016-03-24
Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter (K150046)Zoll Circulation, Inc.2015-10-30
SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER (K141139)Zoll Circulation2014-10-03
COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593 (K101987)Zoll Circulation2010-10-12
INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM (K080908)Innercool Therapies, Inc.- A Delaware Corporation2008-10-17
SOLEX CATHETER, MODEL SL2593 (K081936)Alsius Corp.2008-08-13
ARCTIC BLAST INTRAVENOUS FLUID CHILLER (K080899)Medivance, Inc.2008-08-07
THERMOGARD XP THERMAL REGULATION SYSTEM (K072234)Alsius Corp.2007-08-23

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
TherOx Downstream System (P170027/S018)Zoll Circulation, Inc.2026-04-10
TherOx Downstream System (P170027/S020)Zoll Circulation, Inc.2025-10-29
TherOx Downstream Cartridge (P170027/S019)Zoll Circulation, Inc.2025-06-20
TherOx Downstream System (P170027/S017)Zoll Circulation, Inc.2024-12-19
TherOx DownStream System (P170027/S016)Zoll Circulation, Inc.2024-12-11
TherOx Downstream System (P170027/S014)Zoll Circulation, Inc.2024-10-03
TherOx DownStream System (P170027/S015)Zoll Circulation, Inc.2024-08-14
TherOx Downstream System (P170027/S011)Zoll Circulation, Inc.2024-06-06