The following data is part of a premarket notification filed by Zoll Circulation, Inc with the FDA for 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, Thermogar.
| Device ID | K220008 |
| 510k 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, Thermogar |
| Classification | System, Hypothermia, Intravenous, Cooling |
| Applicant | ZOLL Circulation, Inc 2000 Ringwood Avenue San Jose, CA 95131 |
| Contact | Elizabeth Haines |
| Correspondent | Elizabeth Haines ZOLL Circulation, Inc 2000 Ringwood Avenue San Jose, CA 95131 |
| Product Code | NCX |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | SE - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2022-01-04 |
| Decision Date | 2022-06-02 |