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 HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console

FDA 510(k) clearance K220008 · decided 2022-06-02

Clearance details

K-number
K220008
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 HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console
Applicant
Zoll Circulation, Inc.
Decision
Unknown
Date received
2022-01-04
Decision date
2022-06-02
Days to decision
149 days
Clearance type
Traditional
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 XP Console, Thermogard HQ Console (K223746)Zoll Circulation, Inc.2023-01-13
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