Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit— 510(k) K153226
UnknownZoll Circulation, Inc.
FDA 510(k) clearance K153226 for Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit, Unknown on 2016-03-24. Applicant: Zoll Circulation, Inc..
Clearance details
- Applicant
- Zoll Circulation, Inc.
- Product code
- Code NCX
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Adverse events under product code NCX
product code NCX- Death
- 30
- Malfunction
- 2,302
- Total
- 2,332
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.