The following data is part of a premarket notification filed by Zoll Circulation, Inc. with the FDA for Start-up Kit (suk), Cool Line Intravascular Heat Exchange Catheter, Icy Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter.
| Device ID | K150046 |
| 510k Number | K150046 |
| Device Name: | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter |
| Classification | System, Hypothermia, Intravenous, Cooling |
| Applicant | Zoll Circulation, Inc. 2000 Ringwood Avenue San Jose, CA 95131 |
| Contact | Sam Nanavati |
| Correspondent | Sam Nanavati 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 | 2015-01-12 |
| Decision Date | 2015-10-30 |
| Summary: | summary |