Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console— 510(k) K213031
UnknownZoll Circulation, Inc.
FDA 510(k) clearance K213031 for Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console, Unknown on 2021-12-20. 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.