FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
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
K Number: K220008
·
Decision Jun 2, 2022
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
25
Applicant Total
8
Review Days
149
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Basic Information
- 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
- K Number
- K220008
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5900
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Zoll Circulation, Inc.
- Date Received
- January 4, 2022
- Decision Date
- June 2, 2022
- Product Code
- NCX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NCX | System, Hypothermia, Intravenous, Cooling | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NCX), ordered by most recent decision date.
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
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Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit
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Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Zoll Circulation, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250979 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad) | Oct 15, 2025 | Substantially Equivalent |
| K231182 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System | Nov 3, 2023 | Substantially Equivalent |
| K221700 | AutoPulse NXT Resuscitation System | Mar 9, 2023 | Substantially Equivalent |
| K223746 | 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 | Jan 13, 2023 | Unknown |
| K213031 | 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 | Dec 20, 2021 | Unknown |
| K153226 | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit | Mar 24, 2016 | Unknown |
| K150046 | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter | Oct 30, 2015 | Unknown |