510(k) K052443
- Device
- ICY CATHETER, MODEL IC-3893A
- Applicant
- ALSIUS CORP.
- 510(k) number
- K052443
- Product code
- NCX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-10-17
- Date received
- 2005-09-06
- Regulation
- 870.5900
- Classification name
- System, Hypothermia, Intravenous, Cooling
- Medical specialty
- Cardiovascular
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KENNETH A COLLINS
- Address
- 15770 Laguna Canyon, Suite 150 Irvine CA US 92618 92618
FDA Registration Numbers#
- 2029275
- 3029871637
- 3010617000
- 2024311
Source Documents#
Other 510(k) Records For Product Code NCX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 | Zoll Circulation, Inc. | 2023-01-13 |
| K220008 | 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 | Zoll Circulation, Inc. | 2022-06-02 |
| 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 | Zoll Circulation, Inc. | 2021-12-20 |
| K152946 | TEMPEDY | Seiratherm GmbH | 2016-09-15 |
| K153162 | Hypocore | Novocor Medical Systems, Inc. | 2016-05-24 |
| K153226 | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit | Zoll Circulation, Inc. | 2016-03-24 |
| K150046 | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter | Zoll Circulation, Inc. | 2015-10-30 |
| K141139 | SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER | Zoll Circulation | 2014-10-03 |
| K101987 | COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593 | Zoll Circulation | 2010-10-12 |
| K080908 | INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM | Innercool Therapies, Inc.- A Delaware Corporation | 2008-10-17 |
| K081936 | SOLEX CATHETER, MODEL SL2593 | Alsius Corp. | 2008-08-13 |
| K080899 | ARCTIC BLAST INTRAVENOUS FLUID CHILLER | Medivance, Inc. | 2008-08-07 |
| K072234 | THERMOGARD XP THERMAL REGULATION SYSTEM | Alsius Corp. | 2007-08-23 |
| K071358 | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM | Radiant Medical | 2007-06-01 |
| K071008 | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM | Radiant Medical | 2007-05-09 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases