The following data is part of a premarket notification filed by Zoll Circulation with the FDA for Solex Intravascular Heat Exchange Catheter.
| Device ID | K141139 |
| 510k Number | K141139 |
| Device Name: | SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER |
| Classification | System, Hypothermia, Intravenous, Cooling |
| Applicant | ZOLL CIRCULATION 2000 Ringwood Ave San Jose, CA 95131 |
| Contact | Susan Noriega |
| Correspondent | Susan Noriega ZOLL CIRCULATION 2000 Ringwood Ave San Jose, CA 95131 |
| Product Code | NCX |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-02 |
| Decision Date | 2014-10-03 |
| Summary: | summary |