Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter, Model IC-4593
FDA 510(k) K101987 · Zoll Circulation
510(k) numberK101987
Submission
- Device name
- Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter, Model IC-4593
- Applicant
- Zoll Circulation
Sunnyvale, CA, US - Received
- July 14, 2010
- Decision date
- October 12, 2010
- Decision
- Unknown (SESU)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NCX – System, Hypothermia, Intravenous, Cooling
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5900
- Specialty
- Cardiovascular
Other 510(k)s with product code NCX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K223746 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…NCX · Special | Zoll Circulation, Inc. | 01/13/2023SESU |
| K220008 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…NCX · Traditional | Zoll Circulation, Inc. | 06/02/2022SESU |
| K213031 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…NCX · Traditional | Zoll Circulation, Inc. | 12/20/2021SESU |
| K152946 | TempedyNCX · Traditional | Seiratherm GmbH | 09/15/2016SE |
| K153162 | HypocoreNCX · Traditional | Novocor Medical Systems, Inc. | 05/24/2016SE |
| K153226 | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitNCX · Traditional | Zoll Circulation, Inc. | 03/24/2016SESU |
| K150046 | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular…NCX · Traditional | Zoll Circulation, Inc. | 10/30/2015SESU |
| K141139 | Solex Intravascular Heat Exchange CatheterNCX · Traditional | Zoll Circulation | 10/03/2014SE |
| K080908 | Innercool Therapies, Inc., Rapidblue SystemNCX · Special | Innercool Therapies, Inc.- A Delaware Corporation | 10/17/2008SE |
| K081936 | Solex Catheter, Model SL2593NCX · Traditional | Alsius Corp. | 08/13/2008SE |
More from Alsius Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K250979 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management…NZE · Traditional | 10/15/2025SE |
| K231182 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management SystemNZE · Traditional | 11/03/2023SE |
| K221700 | AutoPulse NXT Resuscitation SystemDRM · Traditional | 03/09/2023SE |
| K223746 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…NCX · Special | 01/13/2023SESU |
| K220008 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…NCX · Traditional | 06/02/2022SESU |
| K213031 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…NCX · Traditional | 12/20/2021SESU |
| K153226 | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitNCX · Traditional | 03/24/2016SESU |
| K150046 | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular…NCX · Traditional | 10/30/2015SESU |
| K141139 | Solex Intravascular Heat Exchange CatheterNCX · Traditional | 10/03/2014SE |
| K112998 | Autopulse Resuscitation System Model 1000DRM · Traditional | 03/15/2012SE |
Questions and answers
When was Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter, Model IC-4593 cleared by the FDA?
Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter, Model IC-4593 (K101987) received a 510(k) decision of Unknown on October 12, 2010, 90 days after the submission was received.
What is the product code of K101987?
The FDA product code is NCX – System, Hypothermia, Intravenous, Cooling, a Class II (moderate risk) device regulated under 21 CFR 870.5900.