The following data is part of a premarket notification filed by Zoll Circulation, Inc. with the FDA for Solex 7 Intravascular Heat Exchange Catheter, Zoll Start-up Kit.
| Device ID | K153226 |
| 510k Number | K153226 |
| Device Name: | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit |
| Classification | System, Hypothermia, Intravenous, Cooling |
| Applicant | ZOLL CIRCULATION, INC. 2000 RINGWOOD AVE. San Jose, CA 95131 |
| Contact | Sam Nanavati |
| Correspondent | Sam Nanavati ZOLL CIRCULATION, INC. 2000 RINGWOOD AVE. 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 | No |
| Date Received | 2015-11-06 |
| Decision Date | 2016-03-24 |
| Summary: | summary |